Actively Recruiting
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
Led by University of Pittsburgh · Updated on 2026-03-18
405
Participants Needed
2
Research Sites
273 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Willing to follow all study instructions and attend all study visits
- Currently have an open diabetic foot ulcer
- Adequate blood flow to the foot shown by at least one: TcOM >30 mmHg, ankle-brachial index ≥0.7, toe pressure >30 mmHg, or TBI >0.6 mmHg
You will not qualify if you...
- Unable to understand study procedures, risks, and benefits
- Wounds closed or planned to be closed by flap or graft
- Marked immunodeficiency such as HIV/AIDS or on immunosuppressive medication
- TcOM less than 30 mmHg
- Hemoglobin A1c above 15 within 3 months before enrollment
- Autoimmune connective tissue disease
- Ulcer size or location prevents TEWL measurement
- Pregnant women
- Prisoners
- Unable to comply with study procedures or complete visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
UPMC Wound Healing Services at UPMC Passavant
Cranberry Township, Pennsylvania, United States, 16066
Actively Recruiting
Research Team
P
Piya Das Ghatak, PhD, MS
CONTACT
S
Shomita S Steiner, PhD, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here