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Can biofilm in foot ulcers predict wound return?

NCT ID NCT05172089

Knowledge-focused Sponsor: University of Pittsburgh 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how biofilm infections in diabetic foot ulcers affect skin healing and whether poor skin barrier function leads to the wound coming back. Researchers will measure water loss through healed skin to check barrier strength. The goal is to understand the link between biofilm and wound recurrence in 405 adults with diabetic foot ulcers.

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 405 people

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

Started

Apr 2024

Expected to finish

Jun 2029

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

clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited for this larger cohort of patients in the parent study.

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: * Male or Female, Age ≥ 18 * Willing to comply with protocol instructions, including all study visits and study activities. * Patient with an open Diabetic Foot Ulcer * Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee): * TcOM \>30 mmHg * Ankle-brachial index at least ≥0.7 * Toe pressure \> 30 mmHg * TBI \> 0.6 mmHg Exclusion Criteria: * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study. * Wounds closed or to be surgically closed by flap or graft coverage * Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications. * TcOM \< 30mmHg * Diabetics with a hemoglobin A1c \> 15 within 3 months prior to enrollment * Subject with autoimmune connective tissue disease * Ulcer size and location that does not allow the TEWL measurement per SOP * Pregnant women * Prisoners * Unable to comply with study procedures and/or complete study visits

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Conditions

The condition(s) this trial relates to.

Diabetic Foot Foot Ulcer Wound Infection

As listed by the trial registrant

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

Biofilm infection Chronic wounds Diabetic foot Diabetic foot infection Trans-epidermal water loss (TEWL)

How to take part

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

  1. The places running it

    2 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

  • UPMC Wound Healing Services at UPMC Passavant

    RECRUITING

    Cranberry Township, Pennsylvania, 16066, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

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