Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot

Not Applicable

Not yet recruiting

• Conditions: Diabetic Foot Ulcer; Type 2 Diabetes Mellitus With Complication

• Registration Number: NCT06770829
• Lead Sponsor: Akdeniz University

Brief Summary

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.

Detailed Description

Diabetic foot, a complication of diabetes, is a significant cause of morbidity and mortality, as well as associated challenges such as high healthcare costs and reduced quality of life. Studies have shown that adherence to treatment among individuals at risk for diabetic foot is consistently low. However, patient education and proper guidance on care can significantly reduce the incidence of foot ulcers. 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 with diabetic foot risk. The development of the Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to play a pivotal role in preventing diabetic foot formation.

Study Design and Methods This study is structured in two phases. In the first phase, the DiaFOOTCare program will be developed, and in the second phase, its effectiveness will be tested through a randomized active-controlled trial.

First Phase: Development of the DiaFOOTCare Program

The DiaFOOTCare program includes various educational and behavioral interventions:

An e-booklet on type 2 diabetes management and preventive diabetic foot care will be prepared. The e-booklet's content will be recorded as voice-over modules, allowing patients to listen to the training at any time during the follow-up period.

A preventive diabetic foot care checklist will be developed to improve patients' knowledge and behaviors related to foot care, accompanied by a training video featuring a simulated patient.

A 20-25 minute face-to-face training session on preventive diabetic foot care will be provided.

A goal-tracking card will be created to enhance diabetes self-management. During the initial interview, three-month individual diabetes management goals will be collaboratively set with the patients and recorded on their tracking cards. Patients will be instructed on how to complete these cards and will be asked to maintain them throughout the three-month period.

To support patients in achieving their diabetes management goals, Short Message Service (SMS) reminder messages will be sent three times a week. The e-booklet, voice-over modules, and video will be shared via WhatsApp or email, ensuring patients can access these materials on their phones or computers.

Second Phase: Testing the DiaFOOTCare Program The second phase will use a randomized controlled trial (RCT) design with single-blinding and an active control group. This phase will be conducted with type 2 diabetic patients at risk for diabetic foot who are treated at the Akdeniz University Hospital Endocrinology and Metabolism Polyclinic and meet the inclusion criteria.

Participants will be stratified based on their diabetic foot risk (categories 2 and 3 of the International Working Group on the Diabetic Foot \[IWGDF\] Risk Classification System) and randomized into two groups using stratified block randomization.

The intervention group (n=39) will receive routine outpatient follow-up along with all components of the DiaFOOTCare program over a three-month period.

The active control group (n=39) will be provided with a brochure on preventive diabetic foot care (available from the Ministry of Health website), explained by the researcher, and shared via WhatsApp or email. The control group will also use the goal-tracking card developed within the DiaFOOTCare program.

Outcome Measures At the end of the three-month period, diabetic foot knowledge, behavior, and self-management scales will be administered to all participants as part of the post-test. Glycemic control will be assessed, and the goal-tracking cards completed by the patients will be evaluated.

Sample Size and Randomization The sample size was calculated using the G\*POWER software based on an 80% power and a 5% significance level. A total of 78 participants will be included in the study, with 39 patients in each group.

To minimize assignment bias, stratified block randomization will be conducted using an independent researcher not involved in the study. This researcher will use a computer-based randomization method to assign participants to groups and will place the group assignments in opaque envelopes for use during the study. By implementing this method, potential bias during the randomization process is effectively controlled.

Study Timeline

• Study First Submitted: 2024-12-04
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02-01
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes Foot Knowledge Scale	12 weeks	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	12 weeks	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	12 weeks	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	12 weeks	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.
Diabetic Foot Development Monitoring Form	12 weeks	The Diabetic Foot Evaluation Form is a comprehensive tool used to assess foot health and identify risks for complications in individuals with diabetes. It evaluates key areas such as skin integrity, presence of ulcers or calluses, vascular health, neurological status, and footwear suitability. The form includes both objective clinical assessments and patient-reported inputs, ensuring a thorough evaluation of foot health. The scoring system typically assigns points to various categories, with a higher cumulative score indicating better foot health and lower scores reflecting higher risk levels or areas requiring intervention. For example, scores might range from 0 to 100, where 90-100 represents excellent foot health, 70-89 indicates moderate risk, and below 70 highlights high-risk patients requiring immediate attention. The form has demonstrated strong reliability, with Cronbach's alpha values ranging from 0.80 to 0.90, indicating excellent internal consistency across its components.
Glycaemic Control Form	12 weeks	The Glycemic Control Form will be used to evaluate and monitor patients' glycemic control through the analysis of key parameters. These include fasting blood glucose levels (mmol/L), postprandial blood glucose levels (mmol/L), and HbA1c levels (percentage). Fasting and postprandial glucose levels provide immediate insights into daily glucose management, while HbA1c reflects average blood glucose levels over the past 2-3 months, offering a comprehensive picture of long-term glycemic control. These metrics will guide the assessment of patients' diabetes management and inform necessary interventions.
Target Tracking Cards	12 weeks	As part of the DiaFOOTCare program, patient goal-tracking cards have been developed to support effective self-management of type 2 diabetes. These cards will facilitate the creation of a three-month individualized goal plan in collaboration with each patient, focusing on adherence to treatment and self-management behaviors. Goals will be set in key areas, including medication adherence, dietary compliance, physical activity, blood glucose regulation, and HbA1c targets. The cards will also document patients' self-reported progress, enabling regular monitoring and adjustment of goals based on their experiences and outcomes. At the end of the three-month period, the information recorded on the goal-tracking cards will be used to evaluate the patient's level of goal achievement and overall progress. This approach ensures a patient-centered, self-report-based method for assessing adherence and facilitating continuous improvement in diabetes management.