DFC 004 Biomarkers for Active Diabetic Foot Ulcers

NCT06104969 | Recruiting DMC

• 1 other identifier: HUM00231478
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Diabetic Foot Ulcer; Diabetic Foot; Diabetes

Keywords

diabetic foot ulcer; Diabetic Foot Consortium

Outcome Measures

Primary Outcomes (8)

• Wound Healing

  Proportion of participants with complete wound healing by week 52, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements at two consecutive study visits 2 weeks apart.

  52 Weeks

• DFU Infections

  Proportion of participants who develop infections of the index DFU among those with no infections at baseline.

  52 Weeks

• Amputations

  Proportion of participants who have an amputation of the limb associated with the index DFU.

  52 Weeks

• Prediction Performance

  Measures of prediction performance (e.g., predictive power, AUC, ROC, Akaike information criterion) of biomarker(s) for each of the clinical outcomes: Wound Healing, DFU Infections, and Amputations described above. Prediction performance is measured by multiple statistical measures to assess ability of the biomarker to predict event risk for each of the three clinical outcomes.

  52 Weeks

• Biospecimens Count

  Proportion of eligible participants providing biospecimens by site, and by type (serum, plasma, wound fluid, wound dressings, wound debridement tissue, urine).

  52 Weeks

• Biospecimen Quality

  Proportion of biospecimens of adequate quality by type.

  52 Weeks

• Standard of Care Prescription by Site

  Proportion of sites that prescribe the most current SOC into usual care, specifically for: (a) offloading; (b) vascular assessment; and (c) debridement.

  52 Weeks

• Standard of Care Adherence

  Proportion of participants who adhere to physician-prescribed SOC therapies for their DFU care.

  52 Weeks

Secondary Outcomes (10)

• Time to Healing

  Up to 52 Weeks

• Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Physical Domain Score

  52 Weeks

• Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Mental Domain Score

  52 Weeks

• Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF subscale leisure score.

  52 Weeks

• Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF physical health subscale score.

  52 Weeks

Study Arms (1)

Diabetic Foot Ulcer

Adult individuals with at least one diabetic foot ulcer who meet inclusion/exclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with diabetes with at least one open diabetic foot ulcer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

ACTIVE NOT RECRUITING

University of California - San Francisco

San Francisco, California, 94143, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Data collected for this study will be analyzed and stored at the DFC DCC at the University of Michigan. After the study is completed, the de-identified, archived data will be transmitted to and stored at the NIDDK Data Repository, for use by other researchers including those outside of the study. With the participant's approval and as approved by the central and local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the DFC Central Laboratory for studies approved by the DFC Steering Committee and eventually in NIDDK Central Repository. Permission for depositing the biological samples in these repositories will be included in the informed consent. The NIDDK Central Repository will also be provided with a code-link that will allow linking the biological specimens with the phenotypic data from each participant, maintaining the blinding of the identity of the participant.

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: October 27, 2023
• Study Start: June 15, 2023
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)