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Can a simple test predict which diabetic foot ulcers will heal?

NCT ID NCT06104969

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This study aims to find biological markers (biomarkers) that can predict whether a diabetic foot ulcer will heal or not. Researchers will collect samples like blood and wound fluid from 5,000 adults with diabetes and open foot ulcers. The goal is to develop a tool that helps doctors make personalized treatment decisions and improve future clinical trials.

What this could mean

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

What this could lead to
If successful, this could lead to a simple test that helps doctors predict which diabetic foot ulcers will heal, enabling personalized treatment decisions.
What could go wrong
This is an observational study, not testing a treatment. It may not identify reliable biomarkers, and results may not apply to all patients.

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.

Participants

About 5,000 people

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

Started

Jun 2023

Expected to finish

Jun 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.

Who is studied

Adults with diabetes with at least one open diabetic foot ulcer.

Ages

18 years and older

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. Provision of signed and dated informed consent form. 2. Age 18 years or older. 3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\] 4. Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU. 5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data. Exclusion Criteria: 1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1. 2. Currently receiving radiation to target area or chemotherapy. 3. Gangrene in any portion of the foot with the index ulcer. 4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0. 5. Severe limb ischemia (SVS WIfl Ischemia grade 3). 6. Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.

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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.

Diabetes Diabetic foot Diabetic foot ulcer

How to take part

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

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Northwell Health

    RECRUITING

    Lake Success, New York, 11042, United States

  • University of Arizona College of Medicine

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California - San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Southern California

    SUSPENDED

    Los Angeles, California, 90033, United States

  • University of Texas Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

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