DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Chemotherapy

Disqualifiers: Gangrene, Severe limb ischemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 52

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

You must provide a signed and dated consent form.

You have been clinically diagnosed with diabetes, or meet the American Diabetes Association criteria.

You have an open foot ulcer extending from the malleolus down, including post-surgical wounds which are left to heal by secondary intention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Testing

Participants undergo biomarker testing to identify diabetic foot ulcers with a higher potential for healing

52 weeks

Visits every other week for one month, then monthly

Follow-up

Participants are monitored for wound healing and recurrence, with assessments at weeks 52 and 78

26 weeks

Phone call or video visit at weeks 52 and 78

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+