New program aims to stop diabetic foot ulcers before they start
NCT ID NCT06770829
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special foot care program (DiaFOOTCare) for people with type 2 diabetes who are at risk of developing foot ulcers. About 78 participants will be split into two groups: one receives the program, the other gets standard care. The goal is to see if the program improves foot care knowledge, self-care habits, and blood sugar control, ultimately preventing foot problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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