Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot (NCT06770829) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot
78 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ex…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on education and self-care behavior for diabetic foot prevention — does my current level of foot care knowledge and my risk for diabetic foot complications make this kind of program worth pursuing, or is there a more immediate medical treatment I should prioritize first?
2The trial is measuring things like foot care knowledge, self-management behavior, and glycemic control — based on where my blood sugar control currently stands, do you think I'm at the right stage to benefit from a preventive program like this, or do we need to get my glucose levels more stable first?
3Since this trial hasn't started recruiting yet, how long might it be before it opens, and is there a similar diabetic foot education or prevention program already available to me in the meantime?
4The study tracks foot development and self-management over time using several monitoring forms — what kind of time commitment and follow-up visits would this likely involve, and is that realistic given my current health situation and schedule?
5Given that this is a non-drug, education-based intervention with no assigned phase, what do you see as the main difference between joining this trial and simply receiving standard diabetic foot care guidance from you or a podiatrist right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.