Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Launched by UNIVERSITY OF PITTSBURGH · Dec 12, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how diabetic foot ulcers (DFUs), which are sores that can occur in people with diabetes, heal when there is a history of biofilm infection. Biofilm infections are when bacteria form a protective layer that makes it harder for wounds to heal. The study aims to find out if wounds that have trouble closing, indicated by a measure called trans-epidermal water loss (TEWL), are more likely to reopen after healing. Researchers will also look at the biological factors involved in how these infections affect the skin's ability to heal.

To participate in this study, you must be at least 18 years old and have an open diabetic foot ulcer. You also need to have good blood flow to your feet, which can be checked using specific tests. This trial is currently recruiting participants, and everyone is welcome to apply. If you decide to join, you will need to attend several study visits and follow certain instructions throughout the trial. It's important to note that some individuals, such as those with certain medical conditions or who cannot understand the study procedures, will not be able to participate.

Gender

ALL

Eligibility criteria

• 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