Understanding biofilm infections in diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with diabetic foot ulcers (DFU) to investigate the relationship between biofilm infections and wound healing. It aims to determine if DFUs with a history of biofilm infection exhibit deficient barrier function, as indicated by high trans-epidermal water loss (TEWL), and whether this deficiency is linked to increased rates of wound recurrence. The study will also explore the molecular mechanisms behind biofilm-induced loss of skin barrier integrity in DFU patients. By analyzing these factors, the research seeks to improve understanding and management of chronic wounds in diabetic patients.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• UPMC Wound Healing Services at UPMC Passavant
  Cranberry Township, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Chandan K Sen, PhD — University of Pittsburgh
• Study coordinator: Piya Das Ghatak, PhD, MS
• Email: piya.dasghatak@pitt.edu
• Phone: 4126240422

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.