Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
University of Pittsburgh
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.
Description
Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (\>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection pos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 m…
Locations (2)
- University of ArizonaTucson, Arizona
- UPMC Wound Healing Services at UPMC PassavantCranberry Township, Pennsylvania