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Diabetic Foot Ulcer Biofilm Infection and Recurrence Study

This observational study is looking at people with open diabetic foot ulcers (DFU). Researchers want to understand if DFUs that have had a biofilm infection (a group of bacteria that stick together) heal with a weak skin barrier. They also want to see if this weak barrier, measured by how much water your skin loses (Trans-epidermal Water Loss or TEWL), leads to the wound coming back. The study will also explore the molecular reasons why biofilm infections might damage the skin's barrier. You can join if you are at least 18 years old, have an open DFU, and have good blood flow to your foot. The study aims to enroll 405 participants. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to enroll 405 participants to understand factors related to diabetic foot ulcer healing and recurrence.
What's involved
You would need to be willing to follow all study instructions, including attending all study visits and activities.
Compensation
Not stated in the trial record.
Follow-up
Biofilm infection abundance will be measured at 16 weeks, and Trans-epidermal Water Loss (TEWL) will be measured at 12 weeks.

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NCT05172089

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Recruiting
Not specifiedAges 18+Observational
University of Pittsburgh
~405 participants
Updated 2026-03-18 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biofilm infection abundance
Measured over 16 weeks
+1 more outcome measured

Conditions

Chronic Wounds
Biofilm Infection
Trans-epidermal Water Loss (TEWL)
Diabetic Foot
Diabetic Foot Infection

Explore related trials

Diabetic foot ulcer

Where it's being run

2 sites across 2 states
Arizona1
Pennsylvania1

Study leadership

  • Chandan K Sen, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Piya Das Ghatak, PhD, MS
[email protected]
4126240422
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Biofilm infection abundance16 weeks

    Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site

  • TEWL12 weeks

    Trans epidermal water loss post closure and 12 weeks