About this trial
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 criteria
Qualifiers
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
TcOM >30 mmHg
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Arizona
Collaborator