Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
United States405 participantsStarted 2024-04-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.