Understanding biofilm infections in diabetic foot ulcers
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
This study looks at how biofilm infections in diabetic foot ulcers affect healing and whether they make wounds more likely to come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 405 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT05172089 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with an open diabetic foot ulcer and adequate arterial blood flow.
Not a fit: Patients with closed wounds, significant immunodeficiency, or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for diabetic foot ulcers, reducing the risk of recurrence and amputations.
How similar studies have performed: While biofilm infections in chronic wounds have been studied, this specific approach focusing on functional wound closure in DFUs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.