Status:
RECRUITING
DFC 004 Biomarkers for Active Diabetic Foot Ulcers
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot Ulcer
Diabetic Foot
Eligibility:
All Genders
18+ years
Brief Summary
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be ...
Detailed Description
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be ...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Age 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\]
- 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.
- Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.
Exclusion
- Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
- Currently receiving radiation to target area or chemotherapy.
- Gangrene in any portion of the foot with the index ulcer.
- Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
- Severe limb ischemia (SVS WIfl Ischemia grade 3).
- 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.
Key Trial Info
Start Date :
June 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06104969
Start Date
June 15 2023
End Date
June 15 2028
Last Update
September 15 2025
Active Locations (8)
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1
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
2
University of Southern California
Los Angeles, California, United States, 90033
3
University of California - San Francisco
San Francisco, California, United States, 94143
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30303