RecruitingNCT05172089
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
Sponsor
University of Pittsburgh
Enrollment
405 participants
Start Date
Apr 2, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria10
- 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
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Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05172089
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