Actively Recruiting

Age: 18Years +
All Genders
NCT06104969

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Led by University of Michigan · Updated on 2025-09-15

5000

Participants Needed

8

Research Sites

261 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Age 18 years or older
  • Clinically diagnosed with diabetes or meeting American Diabetes Association criteria
  • Have an open foot ulcer from the ankle down, including post-surgical wounds healing by secondary intention
  • Agree to follow study visits and provide required biospecimens and clinical data
Not Eligible

You will not qualify if you...

  • Participation in an interventional diabetic foot ulcer clinical trial within 1 month before first visit
  • Currently receiving radiation or chemotherapy targeting the ulcer area
  • Presence of gangrene in any part of the foot with the study ulcer
  • Planned or under evaluation for revascularization of the affected limb within 4 weeks from study start
  • Severe limb ischemia (SVS WIfl Ischemia grade 3)
  • Any medical or psychiatric condition that could prevent safe completion of the study according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

University of Arizona College of Medicine

Tucson, Arizona, United States, 85724

Actively Recruiting

2

University of Southern California

Los Angeles, California, United States, 90033

Active, Not Recruiting

3

University of California - San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

4

Emory University School of Medicine

Atlanta, Georgia, United States, 30303

Actively Recruiting

5

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

6

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

7

Northwell Health

Lake Success, New York, United States, 11042

Actively Recruiting

8

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15219

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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