research on diabetic foot care

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• Malays Orthop J
• v.8(3); 2014 Nov

Knowledge and Practice of Diabetic Foot Care in an In- Patient Setting at a Tertiary Medical Center

Good knowledge and practice regarding diabetic foot care will reduce the risk of diabetic foot complications and ultimately amputation. This study is conducted to assess patients’ knowledge and compliance of diabetic foot care.

A cross sectional study performed on patients who were admitted to HSNZ from the 1st September 2013 to 30th April 2014 for diabetic foot infections. They were interviewed with a questionnaire of 15 ‘yes’ or ‘no’ questions on foot care knowledge and practice. Score of 1 was given for each ‘yes’ answer. The level of knowledge and practice, whether good or poor, was determined based on the median score of each category. The result was tested using a chi-square test in SPSS version 17.

A total of 157 patients were included in this study with a mean age of 56.33 years (31-77). There were 72 male (45.9%) and 85 female (54.1%) patients with the majority of them being Malays (154 patients, 98.1%). Majority of the patients (58%) had poor foot care knowledge while 97 patients (61.8%) had poor diabetic foot care practice as compared to the median score. Based on the chi square test of relatedness, there was no significant association between knowledge and practice with any of the variables.

In conclusion, the majority of patients admitted for diabetic foot infections had poor knowledge and practice of diabetic foot care. Education regarding foot care strategies should be emphasized and empowered within the diabetic population.

Introduction

Diabetes mellitus was found to have affected more than two million Malaysians between the ages of 20 to 79 in 2011 and the number is projected to increase by 50 percent by the year 2030 1 . As the incidence increases, one would expect the number of diabetic complications including diabetic foot complications to rise in the years to come. This potentially devastating sequela causes significant mortality and morbidity and poses a substantial amount of financial burden on our healthcare. A study showed that 12 percent of diabetic related hospital admissions were due to diabetic foot complications 6 . In 2013 at a tertiary center in East Coast Malaysia, out of all these admitted diabetic patients, 11 percent ended up with a major limb amputation 8 . Foot complications increase the risk for amputation in diabetics by 12.3 folds as compared to the normal population 3 . The cost of managing an acute diabetic foot infection in a single admission is approximately RM 32,000 per year or RM190 per patient per year 9 . Diabetic foot complications also have a negative effect on patient’s health related quality of life based on the SF36 questionnaire 10 .

The common component causes of diabetic foot ulcer formation are trauma, neuropathy and deformity 4 . Education and awareness of diabetic foot ulcer pathway and the existing foot care measures that are intended to control them are paramount in foot ulcer prevention strategies. Nonetheless, having knowledge of the foot care alone will not be beneficial unless practiced with good compliance. Efforts have been made to increase public awareness of diabetic foot in the forms of health campaigns, public service advertisements and education by primary healthcare workers. However there are no studies in the literature that assess the current level of awareness of diabetic foot care in our diabetic patients.

The main objective of this study is to determine the level of knowledge and practice of foot care in diabetics who require admission for diabetic foot complications. We would also want to determine the factors associated with the different levels of knowledge and practice of foot care.

Materials and Methods

This is a prospective cross sectional study performed between September 2013 until May 2014 on an in-patient population at Hospital Sultanah Nur Zahirah a tertiary medical center in Kuala Terengganu, Malaysia. A non-randomized convenient sampling method was performed and an informed consent was obtained from the participants. The inclusion criteria was diabetic patients who required admission due to diabetic foot complications such as infected diabetic foot ulcers, cellulitis of the foot, foot abscesses, septic arthritis of the ankle joint, wet gangrene and necrotizing fasciitis of the foot. We excluded patients who were admitted for infection of the lower limb from the level of the calf cephalically such as intra-muscular abscess of the calf, septic arthritis of the knee, thigh abscess and infected transtibial or transfemoral amputation stump. Patients with poor conscious level and clinically delirious or demented were also excluded.

Patients’ demographic data were collected for the purpose of analyzing the factors that were associated with knowledge and practice of diabetic foot care. Information such as age, gender, race and the duration since diagnosed with diabetes mellitus were collected together with educational level and household income per month in Malaysian Ringgit (RM); a local currency. Data regarding duration since diagnosed with diabetes, educational level and household income per month were then divided into two different groups, each. Duration since diagnosed with diabetes was grouped into more and less than 10 years. Educational level was divided into those who studied beyond the Malaysian Certificate of Education (SPM) at tertiary level and those who did not. As with household income the two groups were divided based on monthly income of more or less than RM2000,00.

We used a diabetic foot care questionnaire designed by Hasnain et al, 2 which is a set of 15 ‘yes’, or ‘no’ questions on knowledge and practice ( Table II ). The questionnaire was translated into local language of Bahasa Malaysia and was tested and validated. Medical personnel interviewed all patients during the completion of the questionnaire. It covered good foot care practice in the areas of feet washing techniques, skin and nail care and foot wear care. Each ‘yes’ answer carried one (1) point and zero point for a ‘no’. The points were then added up for each of the knowledge and practice categories. The level of knowledge and practice, whether good or poor, was determined based on the median score of each category. Those who scored more than the median were considered as good and scores lower than the median were considered as poor. The association between duration since diagnosed with diabetes and other socio demographic factors with the level of knowledge and practice of foot care were tested using a chi-square test in SPSS version 17. All data generated and collected were tabulated using a normal frequency table.

Table II : Diabetic foot care questionnaire assessing knowledge and practice. The values are showing positive responses

A total of 157 patients were included in this study with a mean age of 56.33 years (range 31-77) with 94 patients (59.9%) e 55 years or older Table I . There were 72 male (45.9%) and 85 female (54.1%) patients with the majority of them were Malays (154 patients, 98.1%). Only three patients were Chinese (1.9%) from the whole study sample. The mean duration since diagnosed with diabetes was 11.26 years (1-38). Most patients had diabetes for less or equal to 10 years (53.5%). A large majority of the patients earned less than RM2000,00 monthly (120 patients, 76.4%) and only 14 (8.9%) patients had received education beyond the SPM at tertiary level.

Table I : Sociodemographics of diabetic populations Variable admitted for diabetic foot complication

The responses for each foot care measure were generally good except for some in areas of feet washing technique and skin care of the feet ( Table II ). Application of talcum powder in the interdigital space has the lowest positive response with 23.6 percent for knowledge and 15.9 percent for practice. The other foot care measures that received poor responses were: the use of warm water for washing or bathing (47.8% for knowledge, 34.4% for practice); checking the temperature of water before using (31.2% for knowledge, 22.3% for practice) and not to apply lotion in the interdigital space (42.0% for knowledge and 42% for practice). Patients relatively gave satisfactory response to daily change of socks with 52.9 percent for knowledge, however its practice was only 40.8 percent, which was considered poor.

The majority of patients who were admitted for diabetic foot complications had poor foot care knowledge, with 58 percent of them scoring less than the median score of 10. In terms of practice, the number of patients with poor practice was also greater with 97 patients (61.8%) scored less than median score of nine. Based on the chi square test of relatedness ( Table III ) age, gender, household income per month, educational level and duration since diagnosed with diabetes had no significant association with knowledge and practice with none of the variables had p value of less than 0.05.

Table III : Analysis of factors associated with the levels of knowledge and practice

Based on the specific measures of foot care, the ones that received poorest responses were: using warm water for washing and bathing; checking the temperature of water before using; not applying lotion in the interdigital space; and application of talcum powder in the interdigital space. The first two were deemed crucial in diabetic foot care and the latter two might not be as important. Patient should not be using water that is too hot or too cold in washing and bathing as diabetic patients with neuropathy might not be able to feel any insult to their feet and this could lead to catastrophic consequences. Checking the temperature of water before using was also an important step that should be taught to patients so that scald injury could be avoided especially in the feet of diabetics. Keeping the interdigital space dry by applying talcum and avoiding application of lotion was also important to prevent fungal infections as part of foot care hygiene 13 .

This study showed that the majority of patients who were admitted for diabetic foot infections had poor knowledge and poor practice of foot care. In terms of the foot care scoring based on the questionnaire, practice was shown to be lower than knowledge. Median score for knowledge and practice were 10 and 9 respectively. This is a reflection of poor compliance; patients already had a certain level of knowledge of foot care but the practice of that particular knowledge was not always carried out. This finding was comparable with other related studies, which also reported the same pattern of scoring for knowledge and practice of foot care; the score of practice was always poorer than the score of knowledge 2 , 5 , 14 .

An important finding of this study was the non-association of the level of education with the level of knowledge of foot care in diabetic patients. Although the majority of patients who had poor knowledge and practice obtained education only up to secondary level, there was no significant difference when compared to those who received education at tertiary level. Several studies that looked into knowledge and practice of diabetic foot care found that there was a significant association between the level of education with the level of diabetic foot care knowledge 2 , 5 , 14 , 15 . This difference could be explained by the lack of adequate promotion of diabetic awareness in our population. Both educated and less educated patients received inadequate information regarding diabetic foot care.

One might also argue that the population of Terengganu, which is predominantly Malays, has the tendency to believe more in alternative and traditional treatment than modern medicine. According to Ang et al, many of these patients would not accept the loss of a limb even if it were medically required and life saving 12 . Due to their religious beliefs, most of them would want to be buried as a whole person, hence would usually refuse amputation. This type of patients would then opt for alternative medicine with the hope of saving their limb.

Pollock et al reported that women have a significantly higher diabetic foot care knowledge score compared to men in a study conducted in Europe 7 . In some third world countries especially in certain parts of Africa and South Asia, due to socio-cultural beliefs, women were not allowed to attain higher educational status compared to their male counterpart. This had resulted in the discrepancy in the level of knowledge between males and females 5 . however, there is no association between gender and the level of knowledge and practice of diabetic foot care in the present study. In Malaysia, males and females are given the same opportunity for education.

Our study has shown that there was no significant association between patients’ demographics with the level of knowledge and practice of diabetic foot care. Based on our current practice, there are no established guidelines or programs in educating patients during admission or prior to discharge. Although they had multiple admissions for diabetic foot complications, the level of knowledge and practice remained poor. The role of physicians in passing the knowledge to patients is very important in improving the awareness and good practices of foot care. Poor communication between healthcare workers and patients and little amount of time allocated to educate patients due to a busy clinic schedule are usually the reasons for inadequate patient education 5 , 12 , 13 . In addition to that, physicians should always be up to date with the latest information regarding foot care and consistently reinforce the importance of compliance in patients. This should be a routine practice for all diabetic patients in both in and out patient setting. Education of good diabetic foot care practice will increase patient’s confidence in managing their illnesss 11 .

The results of this study should be a reminder for clinicians; nurses and other health care personnel on the importance of improving foot care knowledge and promoting compliance among diabetics. The limitation of this study was that our sample consisted of predominantly Malay patients with a very small number of Chinese patient and no other ethnic groups. This sample does not represent the actual population of Malaysia that consists of several ethnicities. Another limitation was our inability to include all patients that were admitted to our center as the study sample included only diabetic patients who were admitted to the wards of Orthopaedics Department.

Knowledge and practice of foot care in the majority of diabetic patients who were admitted for diabetic foot infections were poor. There is no significant association between patients’ demography with the different levels of knowledge and practice of foot care. Educational programs focusing on awareness of diabetic foot care must directly involve the community, and thereupon in order to reduce the incidence of diabetic foot complications. This should be done in primary care up to tertiary care centers as a multidisciplinary effort.

• Research article
• Open access
• Published: 20 March 2020

Diabetic foot care: knowledge and practice

• Aydin Pourkazemi 1 ,
• Atefeh Ghanbari   ORCID: orcid.org/0000-0002-7949-5717 2 ,
• Monireh Khojamli 1 ,
• Heydarali Balo 1 ,
• Hossein Hemmati 1 ,
• Zakiyeh Jafaryparvar 1 &
• Behrang Motamed 3  

BMC Endocrine Disorders volume  20 , Article number:  40 ( 2020 ) Cite this article

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Diabetic foot ulcers (DFUs) are common problems in diabetes. One of the most important factors affecting the quality of diabetes care is knowledge and practice. The current study aimed at determining the knowledge and practice of patients with diabetes regarding the prevention and care of DFUs.

The current analytical, cross sectional study was conducted in Guilan Province (north of Iran) on 375 patients registered in the medical records as type 2 diabetes mellitus. Demographic characteristics, knowledge, and practice of participants were recorded in a questionnaire during face-to-face interviews conducted by the researcher. Descriptive and inferential statistics were performed using SPSS version18.

The mean score of knowledge was 8.63 ± 2.5 out of 15, indicating that the majority of participants had a poor knowledge (84.8%). The mean practice score was 7.6 ± 2.5 out of 15, indicating that a half of them had poor performance (49.6%). There was a significant and direct correlation between knowledge and practice. Knowledge level, place of residence, marital status, and history of admission due to diabetic foot were predictors of practice score.

Conclusions

According to the low level of knowledge and practice in patients with diabetes regarding the prevention and care of DFUs, and considering the significant relationship of some demographics of patients with knowledge and practice scores, a targeted educational program is needed to promote knowledge of patients with diabetes.

Peer Review reports

What is already known about this subject?

Diabetes accounted for 1.3 million deaths (2.4% of all death). The prevalence of diabetes varies among countries in Eastern Mediterranean Region (EMR).

Prevalence of diabetes mellitus in Iran ranged 20 to 30% in different provinces with higher frequency among females from 1990 to 2013.

Among people living with diabetes mellitus, 20% are at risk for foot ulceration as a result of neuropathy.

Diabetic foot ulcers (DFUs) are one of most common diabetes complications with 0–4% prevalence.

Good knowledge and practice regarding DFU reduces the risk of diabetic foot complications and ultimately amputation.

What are the new findings?

- In the current study, 84.8% of the participants had poor knowledge and only 8.8% had good practice. There was a direct and significant correlation between knowledge and practice.

The lowest knowledge scores belonged to the use of talcum powder or other powders and not using lotions between the toes.

The strongest variables related to practice were knowledge, place of residence, marital status, and history of admission due to diabetic foot, indicating that these four variables were the predictors of practice score.

How might this impact on clinical practice in the foreseeable future?

Patients’ knowledge about foot ulcer prevention should be promoted based on guidelines both in community and hospitals.

Adherence to guidelines prevents DFU; targeted interventions directed toward patients/health care providers can lead to reduced DFU complications.

Diabetes mellitus is a group of common metabolic disease characterized by hyperglycemia. Due to multiple and prolonged complications, diabetes affects almost all systems of the body [ 1 ]. Diabetes caused 1.3 million deaths (2.4% of all death) and 56 million disability adjusted life years (DALYs) in 2013. The diabetes DALY rate increased from 589.9 per 100,000 in 1990 to 883.5 per 100,000 populations in 2013. Total DALYs from diabetes increased by 148.6% during 1990–2013; population growth accounted for a 62.9% increase, and aging and increase in age-specific DALY rates accounted for 31.8 and 53.9%, respectively [ 2 ]. The prevalence of diabetes varies among countries in EMR. In Saudi Arabia, the prevalence of diabetes was reported 13.4% Saudis aged 15 years or older [ 3 ] and in Pakistan 12.1% for males and 9.8% for females aged ≥25 years [ 2 ]. A systematic review on the prevalence of type 2 diabetes in Iran showed a range of 3 to 20% in different provinces [ 4 ].

Of people living with diabetes, 20% are at high risk of foot ulceration as a result of neuropathy [ 5 ]. Diabetic foot ulcers (DFU S ) comprise 12–15% of total estimated cost of diabetes in the developed countries, increasing to 40% in the developing countries [ 6 ]. DFUs are one of the most common diabetes complications with 4 to 10% prevalence in the affected population [ 7 ]. The overall incidence of DFU is 5.8–6.0% in some particular diabetic in the U. S, while it is 2.1–2.2% in smaller populations in Europe [ 8 ]. Treating foot ulcers can be expensive and it is evident that about 49–85% of all DFU S can be prevented by raising awareness and taking proper measures [ 7 ]..

Among the complications of diabetes, DFU S affects the patient’s quality of life in case of amputation. However, it is possible to prevent amputation using educational and care strategies [ 9 ]. Data show that 25% of patients with diabetes develop a foot ulcer in their lifetime and that the cost of treating a DFU S is more than twice that of any other chronic ulcer [ 10 ]. Diabetic foot amputation remains an unpleasant impact on patients’ life more than other complications [ 11 , 12 ]. Delays in referral of serious foot problems are of particular concern [ 5 ]. Ndosi et al., reported that 15.1% of patients died within the year of presentation, the ulcer had healed in 45.5%, but recurred in (9.6%). Participants with a single ulcer on their index foot had a higher incidence of healing than those with multiple ulcers (hazard ratio 1.90, 95% CI 1.18 to 3.06) [ 13 ].

Understanding the level of knowledge and practice in patients with diabetes is important in planning for the better control of diabetes and its complications. A study by Ahmad and Ahmad on 124 patients with diabetes in North India reported that 60.5 and 79.0% got lower scores in knowledge and practice toward diabetes, respectively [ 14 ]. Jackson IL et al., reported that 79.5% of patients with diabetes in Nigeria had more than 70% of overall knowledge about self-care [ 15 ]. The results of a study in Malaysia showed that the most patients (58%) had poor knowledge and 61.8% of them had poor practice of foot care [ 16 ].

Among diabetes complications, the foot ulcers are considered as the most preventable ones. Risk factors of DFU S are correlated with poor practices and knowledge. Good knowledge and practice toward diabetic foot care reduces the risk of diabetic foot complications and ultimately amputation [ 7 ]. According to American Diabetes Association, annual assessments of knowledge, skills and behaviors are necessary for patients with diabetes [ 15 ].. The current study was conducted to assess patients’ knowledge and practice toward diabetic foot care. No similar study is conducted in Rasht City (the capital of Guilan Province, Northern Iran) thus far; therefore, the present study aimed at evaluating the level of practice and knowledge toward foot care in patients with type 2 diabetes mellitus. Health system can prevent DFU and amputation by applying a strategy to raise knowledge in patients.

Study design and subjects

The current analytical, cross sectional study was conducted at a clinic in Razi Hospital, affiliated to Guilan University of Medical Sciences, which is the only endocrine disease referral center across the province. Data were gathered from May to July 2017 and the subjects were selected by consecutive sampling. To Diagnostic and classify the patients, the American Diabetic Association, the diagnostic criteria were utilized [ 17 ]. Patients with diabetes receive care, education, treatment, and other services at this center. The center also delivers healthcare services to outpatients and inpatients, as well as routine training. The research project was approved by the Deputy of Research, Guilan University of Medical Sciences. Participation in the study was voluntarily and the subjects were informed about their right to withdraw from the study at any stage. The participant’s privacy was respected, and data were kept confidential and utilized for study purposes only. Participants were asked to read and sign an informed consent form. Inclusion criteria were: receiving the diagnosis of type 2 diabetes mellitus, age 18 years or above, taking anti-diabetic medications for at least 1 month prior to the study, having clinical records at the center, and willing to participate in the study. The exclusion criteria were: critically ill patients with diabetes, pregnant or newly diagnosed (less than 1 month) patients, receiving any other treatment or therapy, and having major psychiatric problems. A structured datasheet was used to collect demographic and clinical information of the patients using paper-based and digital records archives. Some information was also collected by a medical student through face-to-face interviews. A paper-based questionnaire was distributed among both outpatients and inpatients. Wagner DFU classification system was used to classify the patients based on ulcers. In this hospital, we assessed peripheral neuropathy, retinopathy and peripheral vascular disease (PVD), respectively by using monofilament testing, optometrist or ophthalmologist reports and the clinical diagnosis documented by the surgeon or, if available, images taken through arterial Doppler or angiography. Macro vascular disease was defined as any macro vascular complications other than PVD including prior myocardial infarction, angioplasty, coronary artery bypass grafting, ischemic heart disease, or stroke [ 18 ].

In the current study, having one or two more complications was considered a positive condition. The sample size was determined 375 considering 95% confidence interval with d = 0.05 and P  = 0.58. A total of 375 out of 395 distributed questionnaires were completed and returned; the response rate was 94.4%.

A three-section questionnaire was used in the current study. First section included demographic characteristics such as age, gender, and duration of diabetes mellitus, place of residence, occupation, and level of education, marital status, and body mass index. Second part consisted of 15 questions about knowledge scored based on nominal (yes/no/I don’t know) scale, and third part with 15 questions focusing on practice was scored based on “yes/no” scale. The questionnaire was used to measure the level of knowledge and practice of subjects toward diabetic foot care. Patients’ demographic data were collected to analyze factors associated with knowledge and practice toward diabetic foot care. Each correct answer was given 1 point; however, wrong answers or choosing “I don’t know” option was given 0 point. The total score for each part ranged 0 to 15. Good or poor level of knowledge was determined based on the 75% of the maximum score of the questionnaire; therefore, the scores higher than 11.25 were considered good and those lower than 11.25 were considered poor. Examples of the questions included “Do you care about your diabetes?”; “Do you wash your feet every day?”; “Do you check the water temperature before using it?” and “Do you dry your feet after washing?”

The questionnaire was translated into the Persian language. Following the translations conducted by an Iranian professor of English literature, a native bilingual English speaker translated it back into English. Content validity was determined by gathering the views of 15 medical and nursing professionals after reviewing the questionnaire. Content validity ratio (CVR) and content validity index (CVI) of the questionnaire were assessed. Mean scores of CVI and CVR were higher than 0.80. Cronbach’s α coefficients were computed to evaluate reliability of knowledge and practice, which were 0.80 and 0.85, respectively.

Statistical analysis

After collecting data, descriptive statistics (frequency, mean, and standard deviation) were employed to summarize patients’ socio-demographic data and Chi-square test to investigate association between predictors (factors) and knowledge and practice level. In order to assess the differences between groups, the Wilcoxon, Mann-Whitney, and Kruskal-Willis tests were used for continuous variables. Factors related to knowledge and practice was estimated by multiple regressions. In this research, wrong answers and “I don’t know” merged as poor awareness. In order to assess the relationship between individual variables with knowledge and practice, we had to integrate these two items in order to have a better analysis. Variables with a P -value of < 0.1 were included in the multi-variate models. P -value < 0.05 was considered as the level of significance. All analyses were performed using SPSS version 18.

The mean (± SD) age of the 375 participants was 55.4 (±12.9) years, and 56.4% were female. Majority of patients had diabetes for less than 10 years (54.1%), were female (56.5%), urban residents (62.1%), illiterate or had elementary education (73.1%), did not have normal BMI (69.8%), and (10.6%) patients had 2 and more complications (Table  1 ). In terms of knowledge, only 57 participants (15.2%) had good knowledge, most of them (84.8%) had poor knowledge, and the mean score of patients’ knowledge was 8.63 ± 2.65. The highest percentage of correct answers was found with the knowledge about “The need for meeting or consulting a physician, if there were signs of wounding” (88.8%), followed by “Not walking without shoes” (83.5%) and “Washing and changing socks” (9.81%). The lowest knowledge was about “The use of talcum powder or other powders between the toes” (3.5%), followed by “Not using lotion between the toes” (22.24%), and “The proper method of trimming the toenails” (23.2%).

In terms of practice, only 33 patients (8.8%) had a good practice; most of them (91.2%) had a poor practice (Table  2 ), and the mean score of patients’ practice was 7.6 (± 2.5). The participants reported their best practice toward “Importance of diabetes control” (80.5%), followed by “Meeting or consulting a physician, in case of signs of DFU” (79.2%). The poorest practice was toward “The use of talcum powder between the toes” (2.7%), followed by “Proper method of trimming the toenails” (25.9%), and “Keeping the foot skin soft” (30.9%).

There was a direct and significant correlation between knowledge and practice ( P  < 0.0001, r < 0.8) (Fig.  1 ). There was a significant relationship between knowledge score and gender, duration of diabetes, occupation, level of education, place of residence, having DFU, hospital stay history, and amputation history.

Correlation Between Khowledge and Practice

The study results showed that patients with more than 10 years history of diabetes, history of DFU, history of hospital stay or experience of lower limb amputation due to DFU, female gender, and the ones with complications had higher knowledge ( P  < 0.05).

There was a significant correlation between practice score and gender, duration of diabetes, occupation, level of education, and place of residence (P < 0.05) (Table  3 ).

Also, based on multiple regression, the strongest variables related to practice were knowledge score ( P  < 0.0001), place of residence ( P  < 0.03), marital status ( P  = 0.008), and DFU ( P  = 0.02), indicating that these four variables were the predictors of foot care practices in the current study (Table  4 ).

In the current study, majority of patients with diabetes had lower levels of education. Studies report that level of knowledge depends on the level of education [ 14 , 19 ]. Understanding this variable is highly important in designing strategies to prevent diabetes.

In the current study, most patients had lower scores of knowledge and practice toward foot care, and the mean practice score was lower than the mean knowledge score, which was similar to the findings of Muhammad-Lutfi’s and Kim’s studies [ 16 , 20 ]. A study conducted on patients with diabetes in Western Nepal reported poor KAP (knowledge, attitude and practices) score; they indicated that the plausible factors could be lack of knowledge, lack of information, and literacy level of the studied population [ 21 ]. Another study on young Saudi females with diabetes also reported poor KAP scores [ 19 ]. Some studies reported that patients with diabetes had good level of knowledge about diabetes [ 7 , 16 , 22 , 23 ]. The differences in knowledge about foot care among patients with diabetes across the studies could be due to different trainings on diabetes care provided by the health care professionals in different settings [ 23 ] and also the literacy level of the studied subjects.

Several studies reported poor foot care practices among patients with diabetes. Kheir et al., reported poor practices toward regular inspection of feet among patients in Qatar [ 24 ]. Hamidah et al., from Malaysia observed that 28.4% of patients newly diagnosed with diabetes practiced good habits towards foot care [ 25 ]. Desalu et al., from Nigeria observed that only 10.2% of patients with diabetes had good foot care practices [ 26 ]. It was difficult to compare the results of the current study with those of other studies since the nature of the study populations and the applied measurements were different.

In the current study, there was a direct and significant correlation between knowledge and practice scores; therefore, with an increase in the knowledge score, the practice score also increased. Other studies also showed that patients who receive trainings on foot care checked their feet regularly [ 20 ]. Patients who are advised to take care of their feet and the ones whose feet are regularly checked by physicians have better practices toward foot care [ 27 ].

In the current study, the lowest knowledge scores were regarding the application of talcum powder or other powders and not using lotions between the toes, and the proper way of trimming the toenails; while the lowest practice scores were related to the application of talcum powder between the toes, the proper way of trimming the toenails; keeping the foot skin soft, and avoid dryness.

It should also be noted that due to wet climate in the North of Iran, use of lotion between the toes is not common. Nevertheless, it also needs training. Patients with diabetes need to keep between their toes dry using talcum powder and avoid the application of lotion since it is important as a hygienic measure for feet in preventing fungal infection [ 28 ]. Patients should also use skin moisturizers daily to keep the skin of their feet soft and should trim their toenails straight across (not rounded) to prevent damage to their toes [ 29 ].

In the current study, gender, duration of disease, occupation, place of residence, level of education, having DFU, and a history of hospitalization, amputation, and complication had significant relationships with knowledge. Also, gender, duration of disease, place of residence, occupation, and level of education had significant relationships with practice. It was found that knowledge level was higher in females, patients with a diabetes history of more than 10 years, and the ones underwent amputation due to DFU compared to the others; in addition, females, patients with a diabetes history of more than 10 years, and urban residents had better performance. The current study results showed that males were usually reluctant to disclose their health problems and seek professional care. Also, males presented greater deficit in self-care compared to females [ 30 ].

In the study by Muhammad-Lotfi, age, gender, level of education, and duration of diabetes had no significant relationship with knowledge and practice. This finding was in agreement with that of the current study [ 16 ], but another study indicated a significant relationship between the level of education and knowledge [ 31 ].

People with higher education are expected to be more likely to read and receive information about their illness and foot care and understand the information provided by medical staff in health care settings.

But in the current study, there was no significant relationship between the level of education and knowledge or practice, which could be due to the poor and inadequate resources of information about diabetes at the community level, since both educated and uneducated groups had inadequate information. It may also be due to the fact that in spite of possessing knowledge, due to the lack of time, heavy work load, and lack of adequate insurance coverage, patients could not take good care of their feet in practice, which requires more studies to root out the causes.

Nevertheless, the attitude of patients toward self-care in addition to sufficient knowledge was not studied in the current study. As observed in the present study, patients with a history of DFU or hospital stay, and even amputation and complication had higher knowledge level. It could be due to the fact that while completing the questionnaire, the current knowledge level of the subjects was questioned, which indicated that training medical centers can raise the level of knowledge in patients with DFU. In many Iranian state hospitals, diabetic training programs are not well organized, and the existing programs are weak. It is believed that knowledge about diabetes in the general population as well as patients with diabetes in Iran is not enough and there is a dire need for a good program for diabetes [ 32 ].

The collected data indicated that patients with diabetes had poor practice and knowledge about foot care. This is basically due to lack of proper communication between patients and medical team and inadequate education. Based on nurses’ opinion, recommendations and guidelines play an effective role in prevention, treatment, and reduction of complication among patients with DFU. Therefore, adaptation, implementation, and evaluation of the educational programs were recommended [ 33 ].

Thus, patients should be trained for foot ulcer prevention based on clinical practice guidelines for diabetes mellitus both in the community and hospitals. The results of the current study encouraged a positive outlook: A diabetes educator should give necessary advices to patients during every visit, in order to improve their perception about disease, diet, and lifestyle changes and help them control their glycemic level and overcome the complications of diabetes.

According to the principle of “prevention is better than cure” and considering the predictive factors in the current study including poor knowledge, urban residency, being single, and lack of DFU, more attention should be paid to patients possessing risk factors .

Knowledge and practice toward foot care were poor in most patients with diabetes. There was a significant relationship between some demographic characteristics of patients and knowledge and practice toward foot care. The level of knowledge, place of residence, marital status, and history of hospital stay due to DFU were the predictors of practice in patients with diabetes.

The strength of the current study was that it was the first, study to discuss this important issue in Guilan Province. The study also had some limitations; first, since the work had a cross sectional design, the direction of relationships and causal relationships cannot be determined. Second, the result of the study should be interpreted with caution, since they were obtained from a single center; a clinic-based study. Hospital-based studies cannot provide a true picture of knowledge and practice in the community. The current study sample did not represent the whole Iranian population consisting of several ethnicities. In this research, responses of the wrong answers and “I don’t know” have been grouped together, in order to achieve better analysis. Perhaps with increasing sample size, we could solve this problem in future studies.

Adequate knowledge and good practices are important to effectively control diabetes mellitus. Patients require continuous support of family members and community in order to modify their lifestyle and behaviors and make sustainable changes in order to better control their diabetes disease. Also, education about diabetes mellitus and its risk factors should be provided through mass media in order to effectively control it in the community.

Availability of data and materials

The datasets used and /or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Content validity index

Content validity ratio

Diabetic foot ulcers

Eastern Mediterranean Region

World health organization

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Acknowledgements

The authors wish to thank all the individuals who helped throughout the study, especially Razi Clinical Research Development Center.

The study was funded by the Deputy for Research; Guilan University of Medical Sciences. The funder had no role in the study design, data analysis and interpretation, and writing of the manuscript.

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Aydin Pourkazemi, Monireh Khojamli, Heydarali Balo, Hossein Hemmati & Zakiyeh Jafaryparvar

Social Determinants of Health Research center, nursing and midwifery school, Guilan University of medical sciences, Rasht, Iran

Atefeh Ghanbari

Department of internal medicine , Razi Hospital ,School of Medicine, Guilan university of Medical Sciences, Rasht, Iran

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PA, KM, and GA: the study design; PA,KM and MB: data collection; PA, KM, GA, HH, and BH: data analysis; PA, GA, KM, BH, HH, MB and JZ: data interpretation and drafting of the manuscript. All authors read and approved the final version of the manuscript.

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Pourkazemi, A., Ghanbari, A., Khojamli, M. et al. Diabetic foot care: knowledge and practice. BMC Endocr Disord 20 , 40 (2020). https://doi.org/10.1186/s12902-020-0512-y

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A qualitative study of barriers to care-seeking for diabetic foot ulceration across multiple levels of the healthcare system

• Tze-Woei Tan   ORCID: orcid.org/0000-0002-6658-9482 1 , 2 ,
• Rebecca M. Crocker 3 ,
• Kelly N. B. Palmer 3 ,
• Chris Gomez 4 ,
• David G. Armstrong 1 , 2 &
• David G. Marrero 3  

Journal of Foot and Ankle Research volume  15 , Article number:  56 ( 2022 ) Cite this article

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Introduction

The mechanisms for the observed disparities in diabetes-related amputation are poorly understood and could be related to access for diabetic foot ulceration (DFU) care. This qualitative study aimed to understand patients’ personal experiences navigating the healthcare system and the barriers they faced.

Fifteen semi-structured interviews were conducted over the phone between June 2020 to February 2021. Participants with DFUs were recruited from a tertiary referral center in Southern Arizona. The interviews were audio-recorded and analyzed according to the NIMHD Research Framework, focusing on the health care system domain.

Among the 15 participants included in the study, the mean age was 52.4 years (66.7% male), 66.7% was from minority racial groups, and 73.3% was Medicaid or Indian Health Service beneficiaries. Participants frequently reported barriers at various levels of the healthcare system.

On the individual level, themes that arose included health literacy and inadequate insurance coverage resulting in financial strain. On the interpersonal level, participants complained of fragmented relationships with providers and experienced challenges in making follow-up appointments. On the community level, participants reported struggles with medical equipment.

On the societal level, participants also noted insufficient preventative foot care and education before DFU onset, and many respondents experienced initial misdiagnoses and delays in receiving care.

Conclusions

Patients with DFUs face significant barriers in accessing medical care at many levels in the healthcare system and beyond. These data highlight opportunities to address the effects of diabetic foot complications and the inequitable burden of inadequately managed diabetic foot care.

Peer Review reports

Diabetic foot ulceration (DFU) is a common and often catastrophic complication for people with diabetes. In the United States, people with diabetes have an up to 34% lifetime risk of developing a foot ulcer [ 1 , 2 ], a medical complication that increases their five-year mortality rate by 2.5 times [ 3 , 4 ]. Moreover, foot ulceration is a causal factor for up to 85% of diabetic patients who subsequently undergo lower extremity amputation [ 1 , 5 ]. As compared to the overall United States population, people with diabetes are more likely to undergo lower extremity amputation and repeat amputations [ 1 , 6 ]. The annual medical cost associated with DFU care in the United States is an additional $9–13 billion on top of other costs associated with diabetes [ 7 ].

Moreover, DFUs and subsequent amputations are unevenly patterned along lines of racial and ethnic minority status, low socio-economic status, low insurance coverage rates, and geographic isolation. African American, Hispanic, and Native American adults with diabetes have higher prevalence of DFUs and amputation than their White counterparts [ 8 , 9 , 10 ]. Across the board, patients in the lowest income quartiles experience higher odds of amputation and death due to peripheral artery disease [ 11 , 12 ]. In addition, those with suboptimal or no medical insurance are at an elevated risk of major amputation [ 13 ]. This illuminates a glaring and yet unabated public health problem, especially among minority and low-income populations [ 8 , 9 , 12 , 13 , 14 , 15 , 16 ].

The mechanisms of these observed disparities in DFU incidence and progression are poorly understood [ 9 , 11 , 17 , 18 ]. There is evidence, however, indicating that access to affordable and quality medical care, preventive services, and limb salvage care is an important contributing factor to disparities in amputation rates [ 19 , 20 , 21 ]. This qualitative study aimed to understand patients’ personal experiences with DFUs in a safety net health system, including their processes of navigating the healthcare system and the barriers they faced. The themes elicited in the study concerning multiple barriers at varying levels of the healthcare system will help to improve health care delivery in a population experiencing elevated risks of diabetes-related ulceration and amputation.

This qualitative study was designed to better understand the various challenges faced by patients with a history of DFUs and lower extremity amputations as they managed their conditions and sought medical care. Semi-structured interviews were conducted between June 2020 to February 2021 and the results were analyzed according to the “Health Care System” domain of the National Institute on Minority Health and Health Disparities Research Framework [ 22 ]. The University of Arizona Institutional Review Board approved the study in July 2019 (Protocol Number 1906749805).

Participants

Patients were selected from the Southwestern Academic Limb Salvage Alliance (SALSA), a multidisciplinary limb salvage care team located in Tucson, Arizona, to participate in semi-structured interviews. SALSA treats over 5,000 patient visits annually for diabetic foot problems, of which 40% are from racial and ethnic minority groups. It is the primary referral center for limb salvage and care for minorities and patients with low socioeconomic status in suburban and rural Arizona. Participants were identified and approached for participation during scheduled clinic appointments or by follow-up phone calls by our research team. We purposely sampled participants, using criterion sampling, to reflect the diverse range of race/ethnicity, gender, history of DFU, foot infection, minor amputation (below the ankle), and major amputation (ankle or above) treated by SALSA [ 23 ].

Interview guide and data collection

The research team jointly developed a semi-structured interview guide to encourage patient perspectives regarding their living experiences with foot ulceration and how they sought care for DFUs. Interviews were conducted in the patients’ preferred language (English or Spanish). Three research team members experienced in qualitative interviews (R.M.C., K.N.B.P., and D.G.M.) completed 15 interviews over the phone, lasting 40–60 min each. Interviews were recorded with consent using the “Tape A Call” mobile application ( www.tapeacall.com ) or via the University of Arizona Health Sciences Zoom Platform. The interviews were conducted in phases to allow for simultaneous analysis and redirection of subsequent data collection.

The research team used the Dedoose software version 9.0.17 (SocioCultural Research Consultants, LLC, Los Angeles, CA) to assist in data storage, coding, and data analysis. Audio files of the interviews were transcribed into the language spoken. After a quality assurance check, the transcriptions were uploaded into the software. The transcripts were independently reviewed and coded by three members of the research team (R.M.C., K.N.B.P., and T-W.T.). Data for this article were analyzed according to the NIMHD Research Framework (2017) that includes a multilevel approach including individual, interpersonal, community, and societal-level factors. While this model includes several domains, for the purposes of this paper we are focusing only on the Health Care System domain. This framework has been used in health disparities research to conceptualize and evaluate a wide array of determinants that promote or worsen health disparities [ 24 ]. Team members met regularly to compare coding results and resolve discrepancies by discussion and consensus.

The study sample included 15 participants (Table 1 ). The mean age was 54.2 years. Eleven participants (73.3%) were Medicaid or Indian Health Program beneficiaries and 80% of participants were either unemployed or had retired. All participants had history of at least one DFU, 12 had a history of foot infection, eight underwent minor amputations, and one had a major amputation. Four patients underwent at least one open surgery or endovascular procedure due to peripheral artery disease. During the interviews, participants frequently reported barriers at various levels of the health care system (Table 2 , Fig.  1 ).

Patient reported barriers at all levels influence of the health care system domain

Individual Level of Influence

Health literacy.

While most participants were aware of the risks of foot infection and amputation, there were significant gaps in their health literacy that compromised their ability to make informed decisions about when and how to seek medical care. Most notably, although all participants had a history of DFUs, many were unfamiliar with the term “ulcer” and expressed confusion when interviewers asked questions using that term. This finding, which reflects poor communication by providers and medical staff, resulted in most participants using alternate terms such as “blister,” “callous,” “cut,” “infection,” and “injury” to describe their foot abnormalities. This confusion in terminology was critical, as many patients described not initially seeking medical care because they interpreted their foot abnormality to be a common, everyday problem rather than one warranting medical attention. As one participant described: “Nobody ever really said what I’m looking for just anything that is not normal, I guess. But like I said, I have never heard of a diabetic foot ulcer.” (57-year-old Hispanic male, history of DFU).

In addition, participants described gaps in their health literacy related to the specifics of foot ulcer progression and the appropriate management strategies to prevent amputation. Most participants did not have a solid understanding of warning signs for when medical care should be secured for foot problems or what type of medical care should be sought. One frustrated participant stated: “If I had gotten better, like a different type of information that they could’ve given me, that might’ve helped me improve this ulcer to be going away. From what I have been given, you know, it’s just hard. I don’t know if it’s my foot itself or if it’s the medication. I don’t know. I don’t know if I am a unique case, I know there are people out there that have one foot. And they are able to get, probably, their ulcer better” (29-year-old Native female, history of DFU and recurrent foot infection).

Insurance coverage

While all participants had medical care coverage under Medicaid, Medicare, Indian Health Services or commercial insurance, the majority described significant medical expenses and financial strain related to their diabetes care in general, and in many cases to DFU care in particular. Most of the participants reported multiple recurring expenses such as medications (particularly insulin), co-payments for specialist visits and procedures, and the need for extensive travel, a financial strain that was frequently exacerbated by temporary or permanent loss of employment and under-employment. One participant said that following his second toe amputation: “I was in the hospital for 15 days, 13 days. They are charging me a copay, but I don’t have money to pay it. I am currently not working. I have social security and they don’t give me very much and it’s not enough to cover the copay.” (67-year-old Hispanic male, commercial insurance). In addition, many described substantial out-of-pocket payments for ancillary supplies, such as diabetic footwear and wound dressings due to inadequate insurance coverage, which often resulted in participants being unable to secure the supplies and care they needed for optimal DFU management. For example, a participant explained: “They want me to get diabetic shoes and the orthotic but at the time I didn’t have Medicaid … and with the deductible, they wanted $1,000 for the pair of shoes and the orthotic and I couldn’t afford it.” (45-year-old White female, Medicaid).

Interpersonal Level of Influence

Patient–clinician relationships.

Participants reported a wide array of levels of satisfaction with their medical providers, from long-standing personal and medically supportive relationships to negative experiences of not being listened to or being bounced from provider to provider. A predominant theme involved fragmented relationships with healthcare providers due to multiple factors including patients’ changes in residence, transitions in insurance status, providers leaving the area or switching practices, providers’ medical and holiday leave, and the COVID-19 pandemic. Given the complexity of managing their diabetes and related complications, these interruptions to patient-clinician relationships posed considerable barriers to effective disease management.

In addition, participants mentioned challenges in making timely appointments, and in getting time with their primary care physicians after major clinical events such as hospitalizations. One patient explained: “I had a lot of problems getting in contact with that doctor (primary care doctor). And after, I think it was the first four months after the amputation, and I just kept on trying to contact her… and I would try to call her, and she never returned my calls.” (47-year-old Hispanic male, history of multiple DFUs, foot infection, and toe amputation).

Similar challenges existed around establishing trusting relationships with the nurses that conducted home wound care following DFUs and amputations. This was due in large part to turnover in nursing staff or the rotation of nurses who conducted their home visits. A participant explained: “They [the companies] make a big deal about bringing the nurse in and have them trained on me and then two weeks later, I get a new nurse and redo it.” (45-year-old White female, underwent more than 20 procedures for DFUs).

Lastly, participants reported that the COVID-19 pandemic further intensified this lack of provider continuity due to limited in-person visits. For example, one participant described his struggles to connect with a new endocrinologist during the pandemic, stating: “I see him once and a current situation came up, so I haven’t been able to see him since then. [Due to the pandemic] it has been phone interviews, so, I haven’t really developed any significant rapport with my current endocrinologist.” (41-year-old White male, history of recurrent DFUs and toe amputations).

Community Level of Influence

Availability of services.

Participants commonly reported struggles with getting the medical equipment needed to prevent and manage their DFUs in a timely fashion, including offloading braces, dressing supplies, and therapeutic shoes and insoles. A few noted that the wound supplies provided by the hospital, clinic, or home healthcare companies ran out before their wounds had healed. One participant described maintaining medical supplies as his biggest challenge, saying: “The nurses themselves have been wonderful but their companies have been mainly touch-and-go with maintaining the supplies being delivered at an appropriate time” (41-year-old White male, Medicaid). Despite having prescriptions from physicians and insurance coverage, many participants also faced long waits for securing specialized diabetic shoes from medical supply companies, resulting in delayed or interrupted care. One participant described: "The insoles that I went in for, that they prescribed for me, it took me a long time to get them. Probably like three months after … and then when I got them, they, they were very flimsy, they didn’t last. It took me awhile to get another pair, a better design of the ones that they had” (47-year-old Hispanic male, self-employed, commercial health insurance).

Participants living in rural areas outside of Tucson cited additional challenges in managing their DFUs due to the time, expense, and distance involved in securing the elaborate routines of specialist appointments, routines, medications, and wound care necessary to effectively manage their DFUs. One participant described: “It was a difficulty because I am on the reservation and sometimes the medical things that I would need, like I said, insulin, the IV antibiotics, they wouldn't be able to come out here and do it. If I had lived in a city, then the people would come and get it done.” (38-year-old Native male, Medicare, rural Arizona).

Societal Level of Influence

Quality of care.

Many participants noted insufficient preventative foot care and education prior to DFU onset. Some reported that they did not learn about ulcer prevention until they developed DFUs. For example, one participant stated: “I don’t really remember (doctors) saying anything on ways to prevent other ulcers.” (38-year-old Native male, Medicaid and Indian Health Services). Some participants similarly reported that they did not receive routine foot examinations prior to developing their first DFU, even though they had regularly scheduled primary care appointments. One explained: “Well, early on they didn’t look at my feet. Before I got the ulcer, they didn’t look at them. They would just instruct me to check my blood sugar. But then after the ulcer and when they cut off my toe, that’s when they started to check my feet.” (67-year-old Hispanic male, commercial insurance).

Other barriers presented themselves while seeking adequate medical care for their new ulcers. Participants initially sought care from a variety of different venues— primary care doctors, podiatrists, specialists, emergency rooms, and urgent care clinics— as determined by how serious they interpreted their foot problems and insurance status and access issues. Some participants had the experience of being sent to multiple facilities in search of appropriate care, and those living in rural areas faced travel to different cities or towns. For example, a participant recalled that: “I went to the ER down here in XXX (a community hospital) and that was Friday (was discharged home) and then I saw my doctor on Monday and he sent me to XXX (a tertiary hospital) in Tucson.” (41-year-old White male, history of multiple DFUs and two toe amputations).

Many respondents experienced initial misdiagnoses and delays in receiving care. This included a few participants who presented for diabetic foot complications to acute care facilities, such as urgent care clincs and emergency rooms, and were sent home without an appropriate diagnosis, treatment, and follow-up. One woman recalled her frustrating journey that led to amputation:

‘I called my doctor…. She told me I want you to see an infectious disease doctor and have them put you on an IV antibiotic …. So, I get to the infectious disease doctor, and he says, ‘I’m not going to put you on antibiotic, it isn’t infected.’ So, that’s how I ended up with an amputation because he did not put me on any antibiotic. So, I went into the hospital, and they assigned me an infectious disease doctor and she came in, I’ll never forget this, and she started talking to me like I was stupid, and she goes, ‘You know you’re diabetic, you should’ve gone to a doctor right away ...’ And I said, ‘… hold on a second here, I am a very intelligent person and yes, I did, I went to my own doctor who made an appointment for me to see an infectious disease doctor.” (71-year-old White female, history of multiple DFUs and toe amputations)

Over the past two decades, substantial advances in diabetes therapy have greatly extended health and reduced morbidity. However, as evidenced in this article, significant obstacles to effective DFU treatment and management remain at multiple levels of the healthcare system. Some of these obstacles can be mitigated with more thoughtful education and alignment of access points to receive adequate health care. In this context we offer observations from our study to help address these deficits, particularly as they relate to decreasing notable health disparities.

An important individual level barrier is deficits in health literacy surrounding appropriate terminology to describe diabetic foot complications and how to make informed medical decisions about when to seek medical intervention [ 25 ]. Our findings suggest that a more aggressive and tailored education approach that guides patients to act quickly in seeking medical care and for rapid wound examination is warranted. Part of this education needs to emphasize that diabetes increases the infection and amputation risks of these seemingly “minor” foot injuries. Burdensome expenses related to DFU care posed a second individual level barrier, suggesting the need for continued advocacy for full coverage of DFU care among safety net insurance providers [ 26 , 27 ].

On the interpersonal level, our data illustrate that disruptions to the patient-clinician relationship damages rapport with patients and hinders optimal DFU care. Study participants frequently reported difficulties in accessing appropriate health care providers and disruptions to the patient-physician relationship due to the turnover of providers, changes to region and insurance status, and other factors. This gap calls for developing solutions to address medical provider shortages and to “fill in” health care assessment in a timely manner. One potential approach is to expand the use of trained community health workers who can help triage persons with differing levels of foot ulcers to available health care providers who work outside of the patient’s known environment [ 28 , 29 ].

On the community level, despite having appropriate prescriptions and insurance coverage, participants described significant challenges receiving medical equipment, which was often perceived to be due to shortcomings at the medical supply companies. Since most persons with diabetes see their pharmacist more frequently than any other member of their health care team, developing collaborations between pharmacies, providers, or healthcare system in which pharmacists take on the role of providing medical equipment such as wound care supplies or diabetic shoes, may be an effective approach. Pharmacist supported diabetes care has been shown to be well received by minority patients and to result in improved diabetes outcomes [ 30 , 31 ].

Finally, on the societal level, there is a need to improve preventive care for DFUs on the primary care physician level, a crucial strategy for limb salvage. The American Diabetes Association recommends that all patients with diabetes have their feet inspected at each doctor visit and have a comprehensive foot evaluation at least annually to identify risk factors for DFUs [ 32 ]. Greater focus needs to be placed on educating medical providers and patients, and on the importance of preventive foot care including self-foot inspection, foot examination by a medical professional, and the use of appropriate footwear. In addition, given that sample participants commonly reported receiving misdiagnoses and delays after seeking medical care for DFUs, a standardized protocol and care pathway for when, where, and how patients should seek initial DFU care and how the DFUs should be treated are imperative. Because delays occur both before and after seeking care, a focus must be made to educate both patients and providers about the standard protocol [ 33 ].

There are limitations to this study which should be considered when interpreting the results. Given the relatively modest sample size, we were not able to analyze the data for gender or age effects or by duration of diabetes. Nonetheless, this hard to reach patient sample representing a diverse population did offer very similar stories about the experiences and health disparities they faced in dealing with DFUs.

Diabetic foot ulceration remains a common and life-altering disease complication and one that disproportionately burdens people of racial and ethnic minority status, low socio-economic status, low insurance coverage, and those residing in rural areas. Our study examined the lived experience of a sample of persons with diabetes that face significant barriers at all levels of the healthcare system. Their stories highlight the importance of selecting multiple points of entry to make significant improvements in peoples’ health literacy, relationships with providers, and access to quality and effective medical care, services, and medical supplies. Moreover, this approach should creatively incorporate multiple possible modes of service delivery, including the integration of community health workers and pharmacists. While there are considerable challenges to achieving this goal, concerted efforts are needed to reduce DFUs’ devastating effects on mortality and morbidity and the inequitable burden of poorly managed diabetes foot care among highly affected populations.

Availability of data and materials

The de-identified qualitative data that support the findings of this study are available from corresponding author upon reasonable request.

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Acknowledgements

Our team acknowledge the participants of the study.

The project is supported by a National Institute of Diabetes and Kidney Disease K23 Mentored Patient-Oriented Research Career Development Award (1K23DK122126) and a Society of Vascular Surgery Foundation Mentored Research Career Development Award Program (T-W.T) and a National Institute of Diabetes and Kidney Disease R01 (1R01124789) Award (D.G.A).

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Tze-Woei Tan: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing, Supervision, Project Administration, Funding Acquisition. Rebecca M. Crocker: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. Kelly N.B. Palmer: Conceptualization, Methology, Validation, Formal Analysis, Writing – Review & Editing. Chris Gomez: Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. David G. Armstrong: Conceptualization, Methology, Writing – Review & Editing. David G. Marrero: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. The author(s) read and approved the final manuscript.

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Tan, TW., Crocker, R.M., Palmer, K.N.B. et al. A qualitative study of barriers to care-seeking for diabetic foot ulceration across multiple levels of the healthcare system. J Foot Ankle Res 15 , 56 (2022). https://doi.org/10.1186/s13047-022-00561-4

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TÜRKMEN A, Ezgi SEYHAN AK, ÖZBAŞ A (2021) Research of Knowledge and Attitudes of Patients with Diabetic Foot Ulcer Regarding Foot Care. Int J Diabetes Clin Res 8:144. doi.org/10.23937/2377-3634/1410144

Original Article | OPEN ACCESS DOI: 10.23937/2377-3634/1410144

Research of knowledge and attitudes of patients with diabetic foot ulcer regarding foot care, acelya tÜrkmen 1* , ezgi seyhan ak 2 and ayfer ÖzbaŞ 2.

1 Department of Nursing, Surgical Nursing, Faculty of Health Sciences, Cukurova University, Adana, Turkey

2 Department of Surgical Nursing, Faculty of Nursing, Istanbul University-Cerrahpasa Florence Nightingale, Istanbul, Turkey

Background: This study is conducted to analyze the diabetic foot ulcer patients' knowledge and attitudes regarding foot care.

Methods: Patients diagnosed with type 2 diabetes in the diabetic foot service of a university hospital in Istanbul created the population of this descriptive study. The sample consisted of 73 patients determined by power analysis (95%) and simple random sampling method. A survey form which is consists of 37 questions and created by the researcher is used as the data collection tool. Before beginning the study, the ethics committee approval is obtained. Results are evaluated at a 95% confidence interval and the level of significance is accepted as a p-value of < 0.05.

Results: It is determined that 67.1% (n = 49) of the patients participating in the study are male, 61.6% (n = 45) are married, 95.9% (n = 70) are over 45-years-old, 63% (n = 46) are primary school graduate, and 23.9% (n = 17) had participated in the diabetes education program. In terms of the frequency of doing leg and foot gymnastics, applying cream, walking, shoe control, performing diabetes gymnastics, and selecting socks, there is a statistically significant difference between the patients who engaged in the diabetes education program and the patients who do not (p = 0.00 < 0.05).

Conclusion: It is determined that the majority of patients do not receive training on diabetic foot and do not have a positive attitude about performing certain applications, according to the findings of the study. Concordantly, in order to eliminate the patients' knowledge deficits, it may be suggested that comprehensive and planned training should be provided, the results of the given training should be observed, and the training should be repeated at regular intervals by the nurses, who have a significant role in developing self-care abilities and positive behavioral change in individuals with diabetes.

Diabetic foot, Patient, Knowledge, Attitude, Nurse

Diabetes mellitus (DM) is a metabolic disease that develops due to insulin deficiency, insulin resistance, or a combination of the two. Diabetes mellitus is becoming more common with each passing year, with the number of people living with diabetes expected to rise 1.5 fold from 463 million in 2019 to 700 million in 2045. Diabetic foot ulcers, one of the most serious complications of diabetes, macrovascular disease and microvascular damage accompanied by neuropathy and ischemic problems, which facilitates the development of infection, ulcer and gangrene and eventually causes morbidity and mortality, is a difficult, long and costly health problem [ 1 , 2 ]. The global prevalence of diabetic foot ulcers has been reported to be 6.3% [ 3 ]. Individuals' quality of life suffers as a result of complications caused by diabetic foot ulcers, as well as a rise in mortality and a physical, psychological, and economic burden [ 2 , 4 , 5 ].

The diabetic foot ulcer is a major health issue that necessitates a multidisciplinary approach and has a negative impact on the lives of individuals. The principles of diabetic foot ulcer prevention and treatment include determining the foot at risk, routine foot supervision, patient, family, and healthcare professional education, adequate shoe selection, and treatment of early signs of foot ulcers [ 6 ].

The attitudes of diabetic patients towards foot care significantly reduce the risk of ulcer development. Checking the shoes worn on a regular basis, selecting the right shoes, nail clipping, and daily foot control are among the foot care behaviors that should be performed. Besides, while knowledge is necessary for proper foot care, a lack of knowledge precipitates to the development of diabetic foot ulcers [ 7 , 8 ].

Over the last two decades, research has centered on diabetic patients' foot care knowledge, attitudes, and practices with the aim of recognizing obstacles to seeking medical care, enhancing self-care, and making lifestyle changes [ 2 , 9 , 10 ].

Diabetic foot ulcers are a disorder that can be avoided to a great degree by taking the necessary precautions [ 11 , 12 ]. Diabetic foot ulcers are associated with knowledge and care attitudes. Therefore, diabetic foot ulcers can be avoided by improving the knowledge level of patients about foot care [ 13 , 14 ]. Diabetic patients, according to studies, have an insufficient attitude about foot care and a lack of knowledge about it [ 2 , 14 - 16 ]. 58% of the patients are reported to have little knowledge about foot care in another study, and 61.8% have a more negative attitude about diabetic foot care [ 16 ]. In a study conducted in India, it is observed that very few patients (12.5%) underwent professional foot care training and had little awareness of foot care [ 15 ]. In another study, 82.7% of the patients are reported to have a good level of foot care knowledge, however only 22.4% of them had good foot care practices [ 17 ].

Studies have improved diabetic foot care practice by supporting higher level of knowledge and positive attitude towards diabetic foot care [ 18 , 19 ]. In light of these findings, this study's aim is to analyze the knowledge and attitudes of diabetic foot ulcer patients about foot care, as well as to contribute to the literature with the findings.

Type of the study

This study is conducted to analyze the diabetic foot ulcer patients' knowledge and attitudes regarding foot care.

Population and sample

Patients with type 2 diabetes who are diagnosed with diabetic foot in a university hospital in Istanbul province between March and December 2017 created the study's population. The sample of the study consisted of patients within the universe who gave consent to participate in the study after being informed by explaining the purpose of the study and who have met the study criteria. The sample size for the analysis is calculated using the 3.1 version of the G*Power program, and the appropriate sample size is achieved using the chi-square goodness of fit test. In order to find out whether there is a difference in the attitudes and knowledge levels of diabetic patients regarding foot care, the sample size which is determined for (2-1)*(2-1) 1 degree of freedom and Cohen's effect size of d = 0.33 (since there are people who receive education and those who do not) at 95% confidence level (α = 0.05 and two-way), 0.80 test power (1-β) is calculated as 73 persons. A pilot study was conducted with 10 patients. Patients in the pilot study were not included in the sampling. Patients with type 2 diabetes, diabetic foot ulcers, above the age of 18 who wanted to participate and patients with grade 1-4 ulcers according to Wagner's classification were included in the study. Patients with mental illness, limb amputation and under 18 years of age were excluded from the study.

Data collection

The questionnaire used in the study is prepared by the researchers in line with the literature [ 20 ]. There are a total of 37 questions on the data collection form, which is divided into two parts: 16 questions on demographic characteristics of patients such as age, gender, smoking status, and treatment type in the first part, and 21 questions related to diabetes and diabetic foot care attitude in the second part. Data are collected using the face-to-face interview technique with patients. Face to face interview was conducted by the researcher for 20 minutes.

Ethical considerations

Permission is obtained from both The Clinical Research Ethics Committee (No: 2017-52635) and the hospital where the study would be performed before beginning the study. After giving the patients a clarification about the study, their written and verbal consent are obtained.

Evaluation of data

All data were analyzed using IBM SPSS Statistics, Version 22.0 (IBM SPSS, Statistical Package for the Social Sciences, Turkey) software. Descriptive statistical methods (mean, median, number, percentage) are used in the evaluation. Chi-square tests are used for comparative analysis and independent samples t-test is used for quantitative comparisons. Results are evaluated at a 95% confidence interval and the level of significance is accepted as a p-value of < 0.05.

It is seen in Table 1 that 32.9% (n = 24) of the participants are female, 67.1% (n = 49) are male, 61.6% (n = 45) are married, 95.9% (n = 70) are over the age of 45, 63% (n = 46) are primary school graduates, 32.9% (n = 24) are retired, 20.5% (n = 15) were smokers, 67% (n = 49) are diagnosed with diabetes for more than 6 years, 46.6% (n = 34) used insulin, 90.4% (n = 66) had ulcer treatment, 79.5% (n = 58) had ulcer surgery.

Table 1: Distribution of the Descriptive Characteristics of the Patients (N = 73). View Table 1

However, it is seen in Table 2 that 23.3% (n = 17) of the participants engaged in the diabetes education program, 86.3% (n = 63) thought that patients with diabetes had more ulcers than other people, 80.8% (n = 59) thought patients with diabetes who smoked had more ulcers than non-smokers, 94.5% thought that diabetic patients should regularly perform foot care, 90.4% thought that diabetic patients' feet might have to be amputated due to injuries.

Table 2: Information Status of Patients Regarding Foot Care (N = 73). View Table 2

It is seen that 39.7% (n = 29) of the participants in the study go for a check up once a month, 13.7% (n = 10) do leg and foot gymnastics every day, 64.4% (n = 47) control the water temperature while washing their feet, 75.3% (n = 55) control the color change of the cracked ulcer, 75.3% (n = 55) use cream, 31.5% (n = 23) perform toenail care once a week, 58.9% (n = 43) cut their toenail straight and not too short, 31.5% (n = 23) walk every day, 65.8% (n = 48) do not walk barefoot, 68.5% (n = 50) do not wear slippers and shoes without socks, 53.4% (n = 39) control their shoes, 63% go to the doctor by caring about the ulcer on the foot, 56.2% (n = 41) do not know whether there is diabetes gymnastics or not, 63% (n = 46) wear cotton socks that do not tighten their ankles, 41.1% (n = 30) control the soles of their own feet (Table 3).

Table 3: Distribution of Patients' Attitudes towards Diabetic Foot Care (N = 73). View Table 3

It is found that there is no statistically significant difference (p < 0.05) in knowledge between the patients who have participated in the diabetes education program and those who do not in the study, however, there is a significant difference in attitudes toward diabetic foot care between the two groups. In terms of the frequency of doing leg and foot gymnastics, applying cream, walking, shoe control, performing diabetes gymnastics, and selecting socks, there is a statistically significant difference between the patients who have engaged in the diabetes education program and the patients who do not (p = 0.00 < 0.05) (Table 4). It is observed that the patients who have engaged in the education program exhibited a more positive attitude about the frequency of doing leg and foot gymnastics, applying cream, walking, shoe control, diabetes gymnastics, and selecting socks.

Table 4: Comparison of Patients' Attitudes According to Their Education Status (N = 73). View Table 4

Although diabetes mellitus occurs more frequently in women, diabetic foot, one of the most common complications of the disease, is more common in men [ 21 ]. In the studies of Pourkazemi, et al. [ 14 ] and Ahmed, et al. [ 22 ], it is observed that the majority of patients with diabetic foot ulcers participating in the study are women, while the majority of patients in this study are men. This condition can be explained by the fact that diabetic foot ulcers occur more often in diabetic male patients in the sample due to a lack of routine preventive care behaviors.

Studies show that male gender, smoking, length of illness, cardiovascular disease, and poor glycemic control are the main risk factors for the development of diabetic foot ulcers [ 3 , 18 ]. In diabetic patients, long-term elevated blood sugar leads to a slew of chronic complications [ 1 ]. In their study, Ahmed, et al. [ 22 ] have determined that factors such as education and income levels, long diabetes duration, and family history are all effective in the development of diabetic foot ulcers. Eroğlu and Yürügen [ 1 ] have found in their study that the majority of patients with diabetic foot ulcers had advanced age and long-term (> 16 years) diabetes. It is determined that the majority of the patients in this study also had diabetes for more than 10 years.

Education of diabetic patients is of great importance in preventing and treating diabetic foot ulcers. Knowledge not only aids in the development of a positive attitude but also in making the right decisions about diabetes. Patient behavior directly affects patient consequence [ 20 ].

The inadequacy of education programs regarding diabetic foot and the lack of a team approach to the treatment of complex foot problems are among the possible causes of foot complications in diabetic patients [ 3 , 18 ]. Enabling diabetic patients to acquire knowledge, attitudes, and skills to achieve individual care, and encouraging them to do so will increase their quality of life and reduce their dependence on others [ 23 ]. There are some studies in the literature suggesting that providing individuals with education on diabetic foot leads to improvement in their knowledge, attitudes, and behaviors. In the study conducted by Kafaie [ 24 ], s/he reported that diabetic patients' average foot care scores improved after education. In the study conducted by Al-Hariri, et al. [ 18 ], they have discovered that the majority of patients received education on diabetic foot and had positive attitudes towards foot care. Ahmed, et al. [ 22 ] have found in their study that the knowledge of approximately half of the patients about diabetic foot care is at a good level. In patients with type 2 diabetes, Moradi, et al. [ 23 ] have discovered that education enhanced foot care practices and metabolic control. Alshammari, et al. [ 25 ] have discovered in their study that the majority of the patients are well-educated, with a good level of knowledge and attitudes. On the other hand, several studies have revealed that diabetic patients' foot care knowledge and practices are inadequate [ 14 , 26 - 28 ]. In the study conducted by Isil [ 21 ], it is stated that the majority of diabetic patients did not take diabetic foot care education. The majority of the patients in this study do not have diabetic foot care education, however there is no significant difference between the groups that received education on learning and doing certain practices. This situation can be attributed to the fact that the patients who took part in the study had experience with certain applications as a result of their long-term diabetes.

In both healthy and diabetic individuals, the feet are the most susceptible organs to injury, trauma, and infection. Reduced protective sensation in the feet and toes, slowed blood circulation, dryness and cracks due to a lack of sweating, peripheral vascular disease, and visual impairment all increase the risk [ 29 ]. The fact that patients do not have enough education about foot care raises the risk of trauma and foot ulcers in individuals with diabetes. Daily foot cleaning, creaming, shoe control, nail care, and other applications should all be included in an individual's daily foot care routine. Nural and Hintistan [ 20 ] have determined in their study that patients' protective attitudes towards foot health are low. In the study of Eroğlu and Yürügen [ 1 ], it is found that patients apply cream and have the correct knowledge and practice in selecting socks and shoes. In the study of Kalayci [ 30 ], it is seen that the majority of patients do not use cream and cut their toenails incorrectly, however, they wore cotton socks and placed a high value on shoe preference. Patients who took part in a diabetic foot care education program are observed to have a more positive attitude toward doing leg and foot gymnastics, using cream, walking, shoe control, and choosing socks in this study. Other behaviors such as regulating water temperature, caring for a foot ulcer, and toe-nail care, however, do not show a significant difference between those who are educated and those who are not. The limited content of the education program offered to patients who have had previously been educated could explain these findings. By assessing the patients' lack of knowledge, more comprehensive diabetic foot care educations may be scheduled.

Limitations of the study

The study's findings are limited to diabetic foot patients that are admitted to a hospital's diabetic foot unit, met the research criteria, and agreed to participate in the study.

It is determined that the majority of patients do not receive education about diabetic foot and do not have a positive attitude about performing certain applications, according to the findings of the study. Concordantly, in order to eliminate the patients' knowledge deficits, it may be suggested that comprehensive and planned training should be provided, the results of the given training should be observed, and the training should be repeated at regular intervals by the nurses, who have a significant role in developing self-care abilities and positive behavioral change in individuals with diabetes. By minimizing the lack of knowledge that patients have, possible complications can be avoided and patients' life qualities can be enhanced.

Acknowledgements

We would like to thank all who contributed materially to our study as participating investigators.

During this study, any pharmaceutical company that has a direct connection with the subject of the research, a company that provides and/or produces medical tools, equipment and materials, or any commercial company, during the evaluation process of the study, financial and/or or no moral support was received.

Regarding this study, the authors and/or their family members do not have a scientific and medical committee membership or relationship with their members, consultancy, expertise, working status in any company, shareholding or similar situations that may have a potential conflict of interest.

The study was not produced from the thesis.

This study was presented as a poster at the 16th National Nursing Students Congress held in Istanbul on April 26-28, 2017.

Working Idea and Design: AT, AÖ; Data Collection and Literature Review: AT, Analysis and Interpretation of Data: AT, ESA,; Preparation of Manuscript: AT, ESA, Approval for Final Issue: AT, ESA, AÖ.

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Diabetic Foot Care: Knowledge and Practice

Background: The increase in prevalence of diabetes mellitus (DM) is being associated with many complications among diabetic patients. Foot complications are a leading cause of mortality in developing countries. The aim of this study was to determine the knowledge and practice of foot care among diabetes patients attending the Diabetic Center in Jazan Region, Saudi Arabia.

Methods: Observational cross-sectional study was conducted among a random sample of 250 patients attending Jazan Diabetes Center. Structured questionnaires were administered by medical students to diabetic patients. The outcome variables were knowledge and practice regarding foot care. Descriptive statistics and inferential statistics based on Chi-square test were used for data analysis.

Results: The prevalence of diabetic foot (DF) among males and females was 58.0% and 52.9%, respectively, without significant difference between both sexes. Eighteen percent of study population reported history of foot ulcer. Almost 53.6% patients had good foot care knowledge. Gender, duration of DM, marital status and age had no significant association with knowledge. Males were more adherent to foot drying by 65.2%, while females are applying more attention to softening of skin by 72.3%. There were no significant differences between males and females regarding foot inspection, nail care, adherence to medication and shoes check.

Conclusion: In conclusion, the knowledge and practice of foot care among DM patients in our study participants were not adequate. The result of this study has highlighted the gaps in their knowledge and practice and underscores the urgent need for a patient friendly educational intervention. It is important to activate the role of health education to everyone who has direct contact with the patient, to minimize the DF complications. J Endocrinol Metab. 2016;6(6):172-177 doi: https://doi.org/10.14740/jem388e

ORIGINAL RESEARCH

Research priorities in diabetic foot disease.

Collings R, 1 Shalhoub J, 2 Atkin L, 3 Game F, 4 Hitchman L, 5 Long J, 5 Gronland T, 6 Russell D 7

Plain English Summary

Why we undertook the work : More research is needed to help improve treatment and delivery of care for people with vascular conditions but funding is limited. The Vascular Society of Great Britain and Ireland (VSGBI) ran a Priority Setting Process (PSP) to find out the most important research questions. This helps researchers to better focus their work and helps funders to direct their support to projects that aim to answer these important questions. This paper presents the results of this process, focusing on research priorities related to diabetic foot problems.

What we did : We asked vascular patients and healthcare professionals in separate surveys to suggest their own priorities for vascular research. Responses were summarised and organised into nine overall vascular condition areas. Summary questions were then sent out to the same participants for scoring. The lists of patient and professional priorities were then combined into a shared list for discussion at a final workshop meeting where a mix of patients and their carers with lived experience of diabetic foot problems and healthcare professionals agreed the ‘Top 12’ research priorities for preventing and managing diabetic foot problems research in the UK.

What we found : A total of 481 healthcare professionals and 373 patients or carers submitted research priorities about vascular conditions, which were consolidated into a final combined list of 12 priorities specifically about preventing and managing diabetic foot problems. At a final workshop involving patients, carers and clinicians, these priorities were put into a ‘Top 12’ list ranked according to perceived importance. There was a notable difference between participants who thought risk assessment and prevention of diabetic foot disease was most important and those who felt treating diabetic foot disease and improving outcomes was key. Many participants individually remarked that there was significant overlap between research questions.

What this means : The most important research priorities for the prevention and management of diabetic foot problems have been identified. Researchers and funders are encouraged to focus on addressing these priorities and supporting studies in these areas.

Introduction : Diabetic foot disease is a life-changing event for patients and is associated with high burdens to society in terms of cost, mortality and morbidity. The Vascular Society Diabetic Foot Specialist Interest Group (VSDFSIG), in association with the James Lind Alliance (JLA), aimed to identify and develop key research priorities for preventing and managing diabetic foot disease.

Methods : A modified JLA Priority Setting Partnership was undertaken. Two separate processes to identify research priorities were undertaken with healthcare professionals and patients and carers, led by the VSDFSIG. This exercise produced a list of 12 research priorities. The final workshop was attended by patients, carers and healthcare professionals from a variety of backgrounds involved in the care of people with diabetes and foot pathology. The research priorities were graded to produce a final list of ranked priorities. A final sandpit event addressed the priorities to generate research projects or programmes of research.

Results : A total of 481 healthcare professionals and 373 patients and carers submitted over 100 research priorities relating to diabetic foot disease. These related to diabetic foot disease prevention (including prevention of recurrence and amputation), improving foot outcomes (treatment, risk assessment, blood flow, health promotion) and determining factors that affect healing time (delays in referral, foot infection, antibiotics, larval therapy). Four themes were discussed at the sandpit event relating to potential research projects.

Conclusions : The top 12 research priorities in the prevention and management of diabetic foot disease and potential research projects that will inform researchers, clinicians and funders on the direction of future research priorities are presented.

Introduction

Diabetic foot disease is among a number of serious complications of diabetes mellitus. 1 In the UK there are over 7,000 diabetes-related lower limb amputations each year. 2 Diabetic foot ulceration (DFU) precedes diabetes-related lower limb amputations in 80% of cases, with studies reporting a prevalence of DFUs as between 1% 3 and 2% 4 in people living with diabetes in the UK. Fifty percent of people with diabetes who have suffered a foot ulceration will not live beyond five years. 5

The Global Burden of Disease study ranked diabetes mellitus-related lower extremity complications as 10th on a scale of leading causes of global years lived with disability in 2015. 6 In 2014–2015, the estimated cost attributed directly to DFU and lower limb amputation in the National Health Service (NHS) in England was between £972 million and £1.13 billion. 7 Increased personal and societal costs in terms of psychosocial and physical behaviours 8 and reductions in quality of life 9,10 are also important.

In an attempt to improve the health outcomes and reduce the burden of diabetic foot disease, the Vascular Society of Great Britain and Ireland (VSGBI) created the Vascular Society Diabetic Foot Specialist Interest Group (VSDFSIG) in October 2019. The VSDFSIG comprises a multi-disciplinary team of health professionals alongside patients and/or their carers with an interest in furthering research activity in the field of preventing and managing diabetic foot disease.

One of the first objectives of the VSDFSIG was to establish the research priorities in the prevention and management of diabetic foot disease in the UK. However, there is frequently a mismatch between patients and carers with lived experience of diabetic foot problems and health professionals in selecting and deciding the most relevant research priorities. 11 Bridging this divide is essential to ensure any research is impactful and of relevance to policy makers and research funders. 12

The James-Lind Alliance (JLA) Priority Setting Partnership (PSP) is one such approach to overcome the divide by bringing together patients, their carers and health professionals to identify and prioritise ‘evidence uncertainties’ in specific conditions or areas of healthcare. 13 The PSP methodology aims to make patients and carers as empowered as health professionals in all stages of the process. Using the modified JLA PSP, we aimed to identify and prioritise the most important clinical research priorities in the field of diabetic foot disease, to guide the future research objectives of the VSDFSIG.

Using a modified version of the JLA PSP methodology, the aim was to identify and prioritise the most important diabetic foot disease prevention and management research questions. There were also questions about treatment, communication, education, assessment, service provision and diabetic foot clinical pathways. There was no formal requirement for ethics approval as the JLA PSP methodology is considered public and patient involvement in research and is not research in itself.

The VSDFSIG is a multidisciplinary team comprised of: vascular surgeons and trainees; diabetes physicians; podiatrists; podiatric surgeons; orthopaedic foot and ankle surgeons; vascular nurse specialists; and trial methodologists, all with experience of delivering diabetic foot research, in combination with patient representatives. The VSDFSIG combined with a support team from the Vascular Society and JLA to deliver the research prioritisation partnership.

A health professional-led priority setting process had previously been undertaken by the VSGBI to identify specific research priorities associated with diabetic foot disease prevention and management, details of which have been published previously. 14 A Delphi consensus methodology was used and this process was completed in 2018.

Patient/carer-led research question identification process

A VSDFSIG and JLA-led priority setting partnership was delivered as part of a wider VSGBI initiative, details of which have been published previously. 15 In brief, a first round of survey was open from August 2019 to March 2020 and invited any patients and carers who had been affected by vascular-related disease to submit their priorities for research (Figure 1). The survey was made available in electronic and paper format and was publicised via the following membership bodies; VSGBI, The Society of Vascular Nurses, The Society of Vascular Technicians of Great Britain and Ireland, the Rouleaux Club, BACPAR and BSIR. The survey was also promoted via twitter and in affiliated organisation group newsletters and websites. Similar responses were amalgamated, summarised and duplicates removed. A second round of prioritisation took place from November 2020 to January 2021 and asked participants to rate the importance of the summary list of research priorities using a Likert scale (scores ranged from ‘not at all important’ to ‘extremely important’).

Final consolidation workshop

The final prioritisation process was conducted via a virtual online meeting on 14 June 2021. Nine patient and carer attendees with lived experience of diabetic foot problems were recruited via direct contact from members of the VSDFSIG. Nine healthcare workers were recruited via direct communication with national bodies (eg, VSGBI, Royal College of Podiatry) and via direct links with members of the VSDFSIG.

The workshop was facilitated by the JLA and VSGBI. Members of the VSDFSIG (DR, JS, RC, LA) provided general support during the process, but had no influence over the process of priority setting, observed all sessions (muted with cameras off) and noted key points arising from the discussion.

The seven patient and carer research priorities from the JLA PSP were merged with the six priorities from the health professional PSP, and after removal of a duplicate question, 12 were taken forward to the final prioritisation workshop. One week prior to the workshop, the 12 research priority questions were circulated to attendees. Attendees reviewed and ranked the research questions in order of importance prior to the meeting.

The workshop commenced with an overview of the JLA process. Attendees were divided into three ‘breakout’ groups, each comprising a mix of patients/carers and healthcare professionals. Each breakout group was led by an experienced facilitator skilled in the JLA process.

In the first breakout session, each participant presented their ‘top 3’ and ‘bottom 3’ of the final research priorities. In the second breakout session, having heard a range of perspectives, the same groups were asked to arrange the priorities into a ranked order (numbered 1–12) by mutual discussion. The JLA facilitators collated the priority rank order from each group to generate a combined priority rank order of the research questions.

In the third breakout session, attendees were assigned to different groups for a third round of discussion based on the combined priority rank order, and encouraged to review the order in light of new perspectives. The results of each group’s rank orders were again combined to create a final ordered list. The finalised list of top 12 research priorities was presented to participants in the final workshop plenary to facilitate for reflection and comment.

Results from the clinician-led research priority identification and prioritisation

A total of 481 clinicians submitted 1,231 research priorities relating to vascular surgery in general, of which 75 diabetic foot-related research priorities were submitted. These were reduced to six overarching summary priorities that were recirculated for scoring in the second round of the Delphi consensus.

Patient/carer-led research priority identification and prioritisation

There were 26 priorities related to diabetic foot submitted among 582 research priorities from 373 participants in the first round. Of these, five were excluded as they were individual patient specific and six were moved to other Vascular Society SIGs (3 wound, 3 amputation). The remaining 15 priorities were consolidated into seven overarching research priorities by the VSDFSIG chair and PPI representatives.

As part of the JLA PSP process, the VSDFSIG agreed a list of 12 research priorities (Table 1), derived from the initial survey responses prior to the workshop. The priorities were ordered randomly to reduce the risk of influencing bias and each was assigned an identifying letter (rather than a number).

Following drop-outs on the day, the final consolidation workshop was attended by eight patients/carers and eight healthcare professionals, with an additional four observers from the VSDFSIG. The final top 12 research priority list, in rank order of importance, was defined (Table 2). The third priorities both scored the same score and are therefore ranked equal. Although the original aim was to determine the top 10 priorities, the group felt that all 12 research priorities merited inclusion in the final list.

A number of key points were prominent during the discussions in the workshop. There was a notable difference between participants who thought risk assessment and prevention of diabetic foot disease was most important (priorities 1, 2, 3a, 6, 7 and 10) and those who felt treating diabetic foot disease and improving outcomes was key (priorities 3b, 8, 5, 11, 12). Many participants individually remarked that there was significant overlap between research priorities. For example, priorities 1 and 7 concerned prevention of DFU.

Throughout the discussion, patients/carers expressed frustration with medical terminology, whilst also highlighting a desire to introduce specific timelines into priorities (eg, How long will it take a diabetic foot ulcer to heal?).

After prolonged discussion, the two research priorities numbers 11 (‘Could more patients learn to self-administer antibiotics if needed/required?’) and 12 (‘Is larval therapy effective in diabetic foot ulcer healing?’) were also included. Participants felt that both priorities remained important and are available to be researched.

Sandpit event

Six weeks following the final consolidation workshop, a sandpit event was organised to kick-start the process of generating research projects or programmes of research to address the priorities. This was again conducted online and attended by 16 participants, a mix of clinicians and patients with lived experience of diabetic foot problems. Furthermore, the former comprised a mix of clinical disciplines including vascular surgery, orthopaedic surgery, podiatry and diabetology. Prior to the meeting a mapping exercise was performed by VSDFSIG members to identify past, current and planned research against each research priority to identify the research gaps. Participants split into two groups of similar composition to independently discuss four themes (Table 3) which consider both the priorities and research gaps. Following discussions within the two groups, all participants reconvened and the emerging points were shared and discussed further amongst the complete group. Some of the key points are summarised in Table 3. It was clear that there was overlap and inter-dependence of the themes.

Using a modified JLA PSP methodology, we identified and ranked the principal 12 research priorities in the prevention and management of diabetic foot disease. A two-round process produced 12 priorities for final ranking. Following discussion, consensus was reached with patients, carers and healthcare professionals to produce a top 12 ranked list of clinical research priorities in the prevention and management of diabetic foot disease.

Strengths and limitations

The strengths of this process include the use of the structured and modified JLA PSP process to integrate patients, carers and health professionals’ perspectives on the research priorities in the prevention and management of diabetic foot disease. Facilitation by skilled JLA advisors ensured that all participants contributed actively to the workshop and discussions.

Whilst the VSDFSIG attempted to include a range of participants from different geographical, socioeconomic and different lived experiences of diabetic foot disease, it is recognised that participants might not be truly representative of all stakeholders. However, this was mitigated by implementing the role of VSDFSIG who were able to provide a dedicated review of survey responses and highlight if there were any expected topic areas that could have been missed. Secondly, the risk of responder bias is prominent in this type of research that can limit the generalisability of any findings.

Implications for future research

Establishing the top 12 clinical research priorities will inform the future strategy of the VSDFSIG in contributing to the evidence base for the treatment and management of diabetic foot disease. These priorities will influence researchers and funders to ensure that the most important research priorities for both healthcare professionals and patients are considered. Furthermore, the themes and key points distilled through the subsequent sandpit event are available to the diabetic foot research community as key elements to take forward. The VSDFSIG are available to support any researchers interested in developing research proposals to answer these priorities.

Article DOI:

Journal reference:.

J.Vasc.Soc.G.B.Irel. 2022;1(4):124-129

Publication date:

July 4, 2022

Author Affiliations:

1. Torbay and South Devon NHS Foundation Trust, Torquay, UK 2. Imperial Vascular Unit, Imperial College Healthcare NHS Trust, St Mary’s Hospital, London, UK 3. Mid Yorkshire NHS Trust, Wakefield and University of Huddersfield, Huddersfield, UK 4. Royal Derby Hospital, University Hospitals of Derby and Burton NHS FT, Derby, UK 5. Academic Vascular Surgical Unit Vascular Labs, Hull York Medical School, Hull, UK 6. James Lind Alliance Advisor, National Institute of Health Research, Leeds, UK 7. Leeds Institute of Clinical Trials Research, University of Leeds and Leeds Vascular Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UK

Corresponding author : Dr David Russell Leeds Institute of Clinical Trials Research, University of Leeds and Leeds Vascular Institute, Leeds Teaching Hospitals NHS Trust, Leeds, LS2 9JT, UK Email: [email protected]

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Vascular Society Diabetic Foot Specialist Interest Group : Frank Bowling, University of Manchester, Manchester UK; Andy Cowan, Diabetes UK; Jonathan Cohen, PPI representative; Catherine Gooday, Norfolk and Norwich University Hospitals NHS Foundation Trust; Venu Kavarthapu, King’s College Hospital, London; Sandip Nandhra, University of Newcastle; Pasha Normahani, Imperial College Healthcare NHS Trust, London; Jane Nixon, University of Leeds; James Pickard, Mid Yorkshire NHS Trust; Nung Rudarakanchana, London North West University Healthcare NHS Trust

Data availability : Derived data supporting the findings of this study are available from the corresponding author on reasonable request.

Conflict of Interest : None.

Funding : The James Lind Alliance Priority Setting Project was funded by a grant from the Vascular Society of Great Britain and Ireland.

Acknowledgements : The authors would like to thank the following organisations and charities that supported the VSDFSIG JLA process: VSGBI – Vascular Society of Great Britain and Ireland; BAPO – British Association of Prosthetists & Orthotists; Diabetes UK; Royal College of Podiatry; Faculty of Podiatric Medicine; SVN – Society of Vascular Nurses; VERN – Vascular and Endovascular Research Network; The Rouleaux Club; Circulation Foundation; BSIR – British Society of Interventional Radiology. We would also like to thank all patients, carers and clinicians who responded to the surveys. VSDFSIG team: Leanne Atkin, Frank Bowling, Jonathan Cohen, Andy Cowan, Richard Collings, Frances Game, Catherine Gooday, Louise Hitchman, Venu Kavarthpu, Sandip Nandhra, Jane Nixon, James Pickard, Nung Rudarakanchana, David Russell, Joseph Shalhoub. JLA facilitators: Judith Long, Jonathan Gower, Amy Street, Toto Gronlund. Final prioritisation workshop healthcare professional participants: Carol Amery, Zoe Boulton, Fatima Cassim, Ram Chandrasekar, Patrick Chong, Anna Murray, Craig Nesbitt, Sandip Sarkar, Kaji Sritharan.

Reviewer acknowledgement : JVSGBI thanks the Editorial team for their contribution to the peer review of this work.

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