RECRUITING

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

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Conditions

Diabetic Foot UlcerDiabetic FootDiabetesDiabetic Foot Consortium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-06-15
Study Completion:2028-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06104969

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form.
  2. 2. Age 18 years or older.
  3. 3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\]
  4. 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. 5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.
  1. 1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
  2. 2. Currently receiving radiation to target area or chemotherapy.
  3. 3. Gangrene in any portion of the foot with the index ulcer.
  4. 4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
  5. 5. Severe limb ischemia (SVS WIfl Ischemia grade 3).
  6. 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.

Contacts and Locations

Study Locations (Sites)

University of Arizona College of Medicine
Tucson, Arizona, 85724
United States
University of Southern California
Los Angeles, California, 90033
United States
University of California - San Francisco
San Francisco, California, 94143
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Northwell Health
Lake Success, New York, 11042
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-15
Study Completion Date2028-06-15

Study Record Updates

Study Start Date2023-06-15
Study Completion Date2028-06-15

Terms related to this study

Keywords Provided by Researchers

  • diabetic foot ulcer
  • Diabetic Foot Consortium

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Diabetes