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.
