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New program aims to stop diabetic foot ulcers before they start

NCT ID NCT06770829

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

30 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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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  1. The official record

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