RecruitingNCT06104969

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study

Sponsor

University of Michigan

Enrollment

5,000 participants

Start Date

Jun 15, 2023

Study Type

OBSERVATIONAL

Conditions

Diabetes Diabetic Foot Ulcer Diabetic Foot

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 applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.