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AI on your phone could stop diabetic foot ulcers before they start

NCT ID NCT07185048

Prevention Sponsor: First Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether digital tools, including AI image analysis, can help prevent foot ulcers in people with diabetes at high risk. Over 1,500 participants will be assigned to standard care or one of two digital care programs with different levels of support. The goal is to see which approach best reduces ulcer rates and is easiest for patients to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digital foot care with AI image analysis
What this could lead to
If successful, this could provide an effective, scalable way to prevent diabetic foot ulcers using smartphone-based AI, reducing hospital visits and amputations.
What could go wrong
This is a behavioral intervention trial, not a drug. Results depend on patient engagement and technology reliability. The study hasn't started yet, so outcomes are uncertain.

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 1,512 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

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

50 to 80 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: 1. Age ≥ 50 years but \< 80 years; 2. Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3); 3. Capable of using a smartphone to take photos and operate apps, or able to do so after simple training; 4. Willing to participate in the study and sign an informed consent form. Exclusion Criteria: 1. Currently has an open foot wound or an unresolved foot ulcer; 2. History of major lower limb amputation above the ankle joint; 3. Pregnancy or breastfeeding; 4. Currently suffering from poorly controlled malignant tumors; 5. Receiving glucocorticoid or immunosuppressive therapy; 6. Diagnosed with vascular occlusive vasculitis; 7. Presence of foot fracture; 8. Significant visual impairment affecting image acquisition or operation; 9. Other conditions deemed inappropriate for participation in this study by the research team.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcers (DFUS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.