Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

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

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 ≥0.7-1.20
* 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 \> 12 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

Conditions6

Locations2 sites

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