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.
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
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
clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited for this larger cohort of patients in the parent study.
Other
Prospective
Not listed
Biofilm infection abundance
Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site
TEWL
Trans epidermal water loss post closure and 12 weeks
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Arizona
Collaborator
