Identifying biomarkers for healing diabetic foot ulcers
Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study
This study is trying to find specific markers in the body that can help predict which diabetic foot ulcers are likely to heal, so doctors can better manage treatment for patients with these wounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 8 sites (Tucson, Arizona and 7 other locations) |
| Trial ID | NCT06104969 on ClinicalTrials.gov |
What this trial studies
This observational platform study aims to test multiple biomarkers to determine which diabetic foot ulcers (DFUs) are more likely to heal. By collecting various biospecimens and clinical data from patients with active DFUs in outpatient settings, the study seeks to inform personalized management decisions and enhance future clinical trials for wound healing interventions. The flexible design allows for a wide range of studies relevant to DFUs, ensuring comprehensive data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically diagnosed diabetes and an open diabetic foot ulcer.
Not a fit: Patients with gangrene in the foot or those currently undergoing radiation or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promise in using biomarkers for wound healing, but this platform approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Age 18 years or older. 3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\] 4. Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU. 5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data. Exclusion Criteria: 1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1. 2. Currently receiving radiation to target area or chemotherapy. 3. Gangrene in any portion of the foot with the index ulcer. 4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0. 5. Severe limb ischemia (SVS WIfl Ischemia grade 3). 6. Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.
Where this trial is running
Tucson, Arizona and 7 other locations
- University of Arizona College of Medicine — Tucson, Arizona, United States (Recruiting)
- University of Southern California — Los Angeles, California, United States (Active_not_recruiting)
- University of California - San Francisco — San Francisco, California, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Northwell Health — Lake Success, New York, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.