Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Recruiting now

Conditions studied: Chronic Wounds, Biofilm Infection, Trans-epidermal Water Loss (TEWL), Diabetic Foot, Diabetic Foot Infection

In brief

This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.

Key facts

Study ID

NCT05172089

Run by

University of Pittsburgh

People needed

405

Starts

2024-04-02

Expected to finish

2029-06-27

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Wound Healing Services at UPMC Passavant — Cranberry Township, Pennsylvania, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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