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NCT06770829Not yet recruiting

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

The Effect of a Preventive Diabetic Foot Care Program on Knowledge, Behavior, Self-Management, and Glycemic Control Levels in Patients at Risk of Diabetic Foot

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
78 (estimated)
First submitted
4 Dec 2024
Start date
15 Jun 2026
Primary completion date
1 Jul 2026
Lead sponsor
Akdeniz University
NCT number
NCT06770829

What you commit to

  • Study type: Interventional
  • Planned participants: 78
  • From 15 Jun 2026 to the primary completion date, 1 Jul 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Undergo bariatric surgery during the study.
  • Exhibit non-adherence to prescribed medications.

Other illness

  • 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 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:
  • Have a general health condition that, according to their own statement, is unsuitable for continuing the study.

Other

  • Diagnosed with glaucoma, cataracts, or retinopathy.
  • Voluntarily choose to withdraw from the study.
  • Fail to complete at least two-thirds of the follow-up period for any reason.

Who the study is looking for

  • 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.

Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.