Exploring the Quality of Life of Patients With Diabetic Foot Ulcer: A Cross-Sectional Survey

INTRODUCTION

A diabetic foot ulcer (DFU) is a very disabling long-term complication of diabetes mellitus. The patients are vulnerable to developing long-term complications, which can increase the mortality and morbidity rates.^[1,2] Day by day, the prevalence and incidence rate of DFUs are increasing worldwide. In 2025, an estimated 3.8 million deaths were directly caused by diabetes.^[3,4] The prevalence of DFUs is a growing concern in the regions of middle and low-income countries due to a lack of education and awareness.^[5] A survey has shown that in the states of Karnataka and Punjab, the population is at a significantly higher risk of developing diabetes mellitus. A high prevalence of diabetes was seen in the coastal population of South Karnataka due to their lifestyle changes. A sedentary lifestyle was observed in 11.1% of the study participants, while 41.8% were engaged in moderate physical activity.^[6] Karnataka is one of the top three states in having the highest prevalence of prediabetic individuals. Risk factors such as advanced age, male gender, obese body type, history of hypertension, and diabetes in the family were noted in the urban and rural areas of India.^[7]

The increased incidence of non-traumatic lower extremity amputations and diabetic foot complications remains a silent epidemic in the present era. Action is needed across all areas of quality of life (QOL) to safeguard the well-being of the patients. Raising public awareness about diabetic foot complications is essential for driving preventative measures and reducing amputations. Beyond public awareness, a critical need exists to revolutionise education on diabetic foot management.^[8] The concern reported by a survey is that a significant portion of physicians (67%) in tertiary care settings report poor knowledge about diabetic foot care. This highlights a critical gap in healthcare professionals’ knowledge of diabetic foot care that needs to be addressed.^[9]

DFUs have significantly diminished the QOL of patients due to decreased mobility, increased dependence on others, foot amputation, and frequent hospitalisation. The physical health of DFU patients is much worse than the health of diabetic patients and the general population.^[10,11] Reduction in the quality of life causes decreased satisfaction, changes in the result of treatment, and delays in the healing process.^[12,13] Hence, there is a need to pay attention to the effect of DFUs on the QOL of patients.

MATERIAL AND METHODS

A descriptive study was conducted to determine the QOL of patients (n=100) living with DFUs selected using a purposive sampling technique at a tertiary care hospital in Karnataka. The study was approved by the Scientific Review Board and Institutional Ethics Committee -1 (Protocol no 2019/044). A participant information sheet was provided and explained to the participants to understand the purpose, risks, and benefits, duration of the study, the procedure of data collection, voluntary participation and withdrawal, assurance of privacy and confidentiality of the collected information, and the contact details of the investigators. Time was given to ask any questions regarding participation. Informed consent was obtained from all participants.

The study participants were selected with a predetermined set of criteria. Patients diagnosed with DFUs of more than 8 weeks were included in the study. The patients diagnosed with severe ischaemia of the lower extremity and deep ulcers that have exposure underneath structures such as tendons, bones, or joint capsules were excluded from the study. The information was collected using the socio-demographic proforma and the DFU scale (DFS). The demographic profile consisted of 8 items to obtain information regarding age (years), gender, educational status, occupation status, type of family, family income (Rs)/month, duration of diabetes mellitus, and treatment for diabetes. Permission was obtained from the MAPI research trust to use the DFS. The DFS is the original version of the instrument used to identify the impact of foot ulcers and their treatment on the QOL in people living with diabetes mellitus. It is a 5-item scale (1: not all, 2: a little, 3: moderately, 4: quite a bit, and 5: a great deal). It consists of 28 items that are grouped into 11 domains: leisure, physical health, daily activities, emotions, noncompliance, family, friends, positive attitude, treatment, satisfaction, and finances.^[14,15] To determine the content validity of the tool, it was given to subject experts (n=7). The criterion checklists contained four columns, namely agree, disagree, need modification, and remarks by the experts. The content validity of the tool was obtained, and all the items were 100% in agreement. Permission from the concerned authority of the tertiary care hospital was obtained, and the tool was pretested on a sample of six DFU patients. The trial of the tool was done to determine the clarity of the items, and the time taken to complete the tool was 30-45 minutes. The tool was clear and understandable for the participants. The reliability coefficient (r value) of the tool was calculated using the test-retest method by using Cronbach’s alpha formula. The reliability of the tool was found to be r₍₆₎ = 0.99, which was statistically significant. Reliability values range from 0 to 1, with higher r values indicating greater internal consistency of the tool.

Descriptive and inferential statistics were used to analyse the collected data. QOL data was analysed by computing frequency, percentage, mean, median, mean percentage, and standard deviation. A chi-square test was used to find out the association between the QOL scores and demographic variables of the patients.

RESULTS

The demographic characteristics of DFU patients (n=100) show that 52% of participants were 51-70 years old, 54% were males, 57% were self-employed, and 62% were living in nuclear families. The majority (47%) had been living with diabetes mellitus for 3 to 7 years, and 54% were on insulin therapy for the management of the disease.

The Wagner classification system of categorising DFUs was used in the study to assess the characteristics, depth, and severity of ulcers. The tool scores ranged from Grade 0 (pre-ulcerative) to Grade 5 (whole foot gangrene). In the present study, 38% had pre-ulceration lesions (Grade 0), and 62% of them had superficial ulcers involving skin and subcutaneous tissue (Grade 1). Patients with grade 2 (deep ulcer, exposure of tendon, ligament, joint capsule, or bone), grade 3 (deep ulcer with abscess), and with gangrene/necrosis of the toes or foot were excluded from the study.

The QOL scores are categorised into very good, good, poor, and very poor. Very good indicates a score ranging from 28- 40, good from 41-70, poor from 71-100, and very poor from 101-140. The maximum score is 140, which indicates the QOL is very poor. The higher the score, the lower the QOL. The study results showed that 5% of the study population had very good, 78% were good, and 17% were poor, and none of them had a very poor QOL. The overall QOL was 47.9±12.87, and most of the patients (78%) had a QOL.

Table 1 summarizes the mean individual QOL domain scores of the DFU patients. Scores for family and friends were found to be lower compared to other domains of QOL. Due to the problem of DFUs, spouses and family members had a strain and restricted the kind of activities with their friends. In the present study, a significant association was found between the QOL scores of DFU patients and their educational status (χ²= 0.003) [Table 2].

DISCUSSION

The present study results revealed that among 100 DFU patients, the maximum percentage (52%) of participants were aged between 51-70 years; the majority (54%) were males. Similarly, a cross-sectional study was performed on 60 patients hospitalised for DFU in Iran. Of the 60 patients, 53% were males and 47% were females, with an average age of 58.08±11.95 years.^[16] Many studies showed a significant relationship between age and DFUs. Advanced age and male gender are important risk factors for diabetes mellitus. It is also evident that the incidence of foot ulcers and limb amputation increases with the advanced age of diabetic patients.^[17,18] Many study participants had primary, higher primary education, which was also significantly associated with QOL. Education matters a lot to understanding the disease process and treatment. It also helps to develop a positive attitude towards the treatment regimen.^[19-23] Health status awareness helps prevent long-term complications in diabetic patients. In the present study, most of the participants were self-employed. The financial crisis is seen in patients with DFUs due to high-cost medical treatment, insulin regimen, amputation, and other therapies.^[24-26] In the present study majority belonged to nuclear families. Family support is essential in caring for and managing patients with foot ulcers. A foot ulcer restricts the activities of patients and makes them dependent on others for their self-care.^[27-29] Patients living in nuclear families experience difficulties in managing emotional and financial stability. Many research studies showed that long-duration type 2 diabetes mellitus, more than 10 years, was associated with the QOL of patients.^[30-32] The treatment of diabetes varies from patient to patient, including anti-diabetic drugs, insulin therapy, lifestyle modification, and/ or combination with other therapies. Long-term treatment affects the quality of life of diabetic patients, and the role of healthcare personnel is very important in recognising their health needs.^[33,34]

The majority (78%) of DFU patients in the present study had a good QOL, 17% had a poor QOL, 5% had a very good QOL, and no patients had a very poor QOL. Similarly, a study was carried out among patients (n=146) with type 2 diabetes mellitus. The results revealed that the mean age of the patients was 60.07 years. The present study’s findings highlighted the need to enhance the social support network, which includes the role of family and friends in caring for DFU patients. The involvement of spouse and family in care and the contribution of friends are vital to the enrichment of QOL. Many studies have shown the importance of family and friends in improving the QOL of patients.^[27-29]

Physical health, daily activities, and emotions were not affected much in the study participants.

Assessment and management of impaired QOL are some of the most neglected elements in the care of DFU patients. Routine assessment of the physical and psychological health of the patients is necessary to improve their lives. Early identification of health issues helps in planning remedial measures, such as awareness programs, training, counselling, and medical assistance. Unfortunately, in the busy work schedule of tertiary care hospitals, there is often little time to assess the patients’ physical and mental health needs.^[19] Moreover, healthcare professionals may not be trained enough to recognise early changes in the diminishing QOL of patients. Many studies have concluded that education and training programs for healthcare professionals are necessary to identify these changes at the earliest time to decrease complications.^[34] The present study also had some limitations. A smaller sample size, recruited from an inpatient department of a single tertiary care setting, constrained these results to a wider range of DFU populations. This cross-sectional study was carried out at a single point in time with no follow-up. The domains of QOL over time could not be assessed. Another limitation was the restriction of study participants to patients with pre-ulceration lesions (Grade 0), superficial ulcers involving skin and subcutaneous tissue (Grade 1). Other patients with deep ulcers and gangrene were included in the study.

CONCLUSION

The study revealed that DFU patients had a good QOL. However, there is a need to enhance social support networks, which adversely affect QOL. The study also encourages training programs for healthcare professionals to recognise early changes in patients’ deteriorating QOL. The present study findings conclude that educational status is associated with reduced QOL, which affects the health of caregivers, and there is a need to educate them in the management of diabetes mellitus.