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

Launched by AKDENIZ UNIVERSITY · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new program called DiaFOOTCare, which is designed to help patients with type 2 diabetes who are at risk of developing diabetic foot problems. The goal is to improve their knowledge about foot care, encourage better self-management of their diabetes, and help control their blood sugar levels. The program will be tested in two phases. First, experts will create the foot care program and try it out with a few patients to gather feedback. Then, a larger group of patients will be involved in a randomized controlled trial, where some will receive the DiaFOOTCare program, while others will not, allowing researchers to see how effective the program really is.

To be eligible for this study, participants must be between 30 and 65 years old, have type 2 diabetes for at least six months, and have specific risk factors for foot problems. They also need to be literate and have internet access to participate. If you join the trial, you can expect to learn more about preventing foot issues, receive support for managing your diabetes, and contribute to important research that could help others in the future. It's essential to know that participation requires commitment, and some health conditions may exclude individuals from the study.

Gender

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Eligibility criteria

• • Inclusion Criteria
• Participants must meet all of the following criteria to be included in the study:
• • 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.
• • Literate.
• • No physical or mental disabilities that would prevent answering the study questions.
• • No communication barriers.
• • Able to understand and verbalize their diagnosis.
• • HbA1c ≥7.5%.
• • Internet access at home and possession of a device such as a computer, tablet, or smartphone, with the ability to use these tools.
• • Willing to provide informed consent to participate in the study.
• • Exclusion Criteria
• Participants will be excluded if they meet any of the following conditions:
• • 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.
• • Diagnosed with glaucoma, cataracts, or retinopathy.
• • Diagnosed with a terminal illness.
• • Inability to provide accurate information or participate in the study.
• • Criteria for Exclusion During Follow-Up
• Participants will be excluded from the study during the follow-up period if they meet any of the following conditions:
• • Voluntarily choose to withdraw from the study.
• • Fail to complete at least two-thirds of the follow-up period for any reason.
• • Undergo bariatric surgery during the study.
• • Exhibit non-adherence to prescribed medications.
• • Have a general health condition that, according to their own statement, is unsuitable for continuing the study.