NCT05172089 · University of Pittsburgh
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
(DFUBiofilm)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Biofilm infection abundance
Time frame: 16 weeks
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
Time frame: 12 weeks
Trans epidermal water loss post closure and 12 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Unable to comply with study procedures and/or complete study visits
Where
- Tucson, Arizona
- Cranberry Township, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations