NCT05172089 Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
| NCT ID | NCT05172089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Chronic Wounds |
| Study Type | OBSERVATIONAL |
| Enrollment | 405 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2028-06-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 405 participants in total. It began in 2024-04-02 with a primary completion date of 2028-06-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 at least ≥0.7 * 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
Contact & Investigator
Chandan K Sen, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05172089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Wounds. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05172089 currently recruiting?
Yes, NCT05172089 is actively recruiting participants. Contact the research team at piya.dasghatak@pitt.edu for enrollment information.
Where is the NCT05172089 trial being conducted?
This trial is being conducted at Tucson, United States, Cranberry Township, United States.
Who is sponsoring the NCT05172089 clinical trial?
NCT05172089 is sponsored by University of Pittsburgh. The principal investigator is Chandan K Sen, PhD at University of Pittsburgh. The trial plans to enroll 405 participants.