About this trial
This study aims to evaluate the effect of a preventive diabetic foot care program on the knowledge, behavior, self-management, and glycemic control levels of type 2 diabetic patients at risk of diabetic foot. The development of a Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to make a significant contribution to preventing diabetic foot formation. The DiaFOOTCare program consists of two stages. In the first phase, a comprehensive, multi-component, and evidence-based preventive diabetic foot care program will be designed specifically for type 2 diabetic patients at risk of diabetic foot. The internal validity of the program will be tested through expert evaluations by specialists in diabetic foot care, assessments using readability formulas, and pre-application testing with patients identified as being at risk of diabetic foot. As part of the final implementation of the first phase, all interventions included in the DiaFOOTCare protocol will be administered to four patients with diabetic foot risk over a three-week period. Following this, the DiaFOOTCare protocol will be evaluated based on the feedback provided by these four pre-application participants. In the second phase, a randomized controlled trial (RCT) with a single-blinded and active control group design will be conducted at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A group of patients with type 2 diabetes and diabetic foot risk will be identified, and pre-tests will be administered. The patients will then be randomly assigned to the intervention group (n=39) and the control group (n=39). The effectiveness of the DiaFOOTCare program will be assessed through post-tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with type 2 diabetes receiving follow-up and treatment at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic.
Presence of one or more diabetic foot risk factors, categorized as category 2 or 3 according to the IWGDF (International Working Group on the Diabetic Foot) Risk Classification System.
Diagnosed with type 2 diabetes for at least six months.
Aged between 30 and 65 years.
Disqualifiers
Myocardial infarction, stroke, heart failure, or angina pectoris within the last year.
Diagnosed with type 1 diabetes or gestational diabetes.
Presence of an active diabetic foot ulcer.
Diagnosed with dementia or cognitive deficits.
Trial design
Parallel
Treatments tested in this trial
DiaFOOTCare Program
BehavioralThe DiaFOOTCare Program includes initiatives to support diabetic foot self-management. An e-booklet on type 2 diabetes management and preventive foot care will be shared via WhatsApp or email, along with audio modules for convenient access. An interactive video featuring a simulated patient will visually demonstrate preventive foot care practices and will also be shared digitally. A 25-30-minute face-to-face training session will provide personalized education using a tablet. Goal-tracking cards will be introduced to collaboratively set three-month behavioral goals, with patients documenting their progress during the follow-up. SMS reminders will be sent three times weekly to reinforce adherence. Patients will have digital access to all DiaFOOTCare resources, including the e-booklet, audio modules, and video, for 12 weeks, ensuring accessibility via WhatsApp or email. These measures aim to enhance knowledge, behavior, and self-management practices in preventive diabetic foot care.
Ministry of Health and Education
BehavioralThe active control group will receive routine outpatient follow-ups and a diabetic foot care brochure from the Ministry of Health, explained by the researcher and shared via WhatsApp or email for reference. Goal-tracking cards from the DiaFOOTCare program will be used to set individual diabetic foot self-management behavioral goals collaboratively during the initial interview. Patients will be instructed on how to complete the cards and maintain them over a three-month period. At the end of the follow-up, post-tests will assess outcomes using the Glycemic Control Form, Goal-Tracking Card, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale, Nottingham Functional Foot Care Diagnostic Form, Diabetic Foot Development Follow-up Form, and Diabetic Foot Self-Management Scale. Educational resources, including the e-booklet, audio modules, and video developed in DiaFOOTCare, will also be shared via WhatsApp or email to provide additional support and enhance diabetic foot self-management.
Treatment groups
Trial outcomes
Primary outcomes
Diabetes Foot Knowledge Scale
The Diabetic Foot Knowledge Scale is a validated tool designed to assess individuals' knowledge of diabetic foot care and complications. It evaluates key areas such as risk factors, preventive strategies, warning signs, and footwear selection. The scale typically includes 20 items, with each correct response earning 1 point, resulting in a score range of 0 to 20. Higher scores indicate strong awareness and reduced risk of complications, while lower scores highlight knowledge gaps requiring targeted education. Psychometric properties include a Cronbach's alpha of 0.63, indicating acceptable internal consistency, and an intra-item correlation coefficient of 0.25. The scale is widely used in clinical and research settings to identify at-risk patients, evaluate educational interventions, and guide strategies to improve diabetic foot self-management. Its practical design makes it a valuable resource for promoting preventive care and reducing diabetic foot complications.
Diabetic Foot Behaviour Scale
The Diabetic Foot Behavior Scale is a tool designed to evaluate foot self-care behaviors in individuals with diabetes. The scale consists of 15 items within a single dimension, utilizing a 5-point Likert-type format with responses scored as "Never," "Occasionally," "Sometimes," "Often," and "Always." Total scores range from a minimum of 15 to a maximum of 75, with higher scores indicating better self-care behaviors. The scale has demonstrated good internal consistency, with a reported Cronbach's alpha of 0.83.
Nottingham Functional Foot Care Diagnosis Form
The Nottingham Functional Foot Care Diagnosis Form is a comprehensive tool designed to assess foot care practices and identify areas for improvement in individuals with diabetes or other conditions affecting foot health. The form evaluates multiple aspects of foot care through subscales, including hygiene and skin care, nail care, footwear, inspection and monitoring, and symptom management. Responses are scored using a numerical system, often based on frequency or quality of behaviors, with higher scores indicating better foot care practices and lower scores highlighting areas needing improvement or intervention. The form has demonstrated excellent reliability and validity, with Cronbach's alpha values ranging from 0.80 to 0.90, confirming its strong internal consistency.
Diabetic Foot Self-Management Scale
The Diabetic Foot Self-Management Scale is a validated tool designed to evaluate self-management behaviors related to diabetic foot care and their impact on glycemic control in patients with diabetes. The scale comprises 16 items that assess various aspects of self-care, including regular foot inspections, appropriate footwear selection, and management of foot-related symptoms. Each item is scored on a Likert-type scale, typically ranging from 1 (never) to 5 (always), resulting in a total score range from 16 to 80. Higher scores indicate better adherence to diabetic foot self-management practices, reflecting a proactive approach to preventing complications such as ulcers or infections. The scale has demonstrated strong reliability, with a reported Cronbach's alpha of 0.85, indicating excellent internal consistency.
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