DFC 004 Biomarkers for Active Diabetic Foot Ulcers

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

Conditions

Diabetic Foot Ulcer, Diabetic Foot, Diabetes

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Study Overview

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Study Details

Study overview

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

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

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona College of Medicine, Tucson, Arizona, United States, 85724

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

San Francisco

University of California - San Francisco, San Francisco, California, United States, 94143

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Lake Success

Northwell Health, Lake Success, New York, United States, 11042

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Study Record Dates

2028-06-15