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Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Recruitingn/aAges 18 Years - anyAllUniversity of Pittsburgh
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or Female, Age โ‰ฅ 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 โ‰ฅ0.7 * 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
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What it tests

  • Not listed
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Where

2 sites
University of Arizona
Tucson, United States
UPMC Wound Healing Services at UPMC Passavant
Cranberry Township, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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