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C-myc Biomarker Study for Diabetic Foot Ulcers | Clinical Trials | Clareo Health

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C-myc Biomarker Study for Diabetic Foot Ulcers

Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers - C-myc and Phosphorylated Glucocorticoid Receptor

NCT04591691•University of Michigan

Summary

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•In order to be eligible to participate in this study, an individual must meet all of the following criteria:
•1. Provision of signed and dated informed consent form
•2. Stated willingness to comply with all study procedures and availability for the duration of the study
•3. Male or female, aged 18 years or older.
•4. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
•5. Foot ulcer of diabetic etiology, with all of the following characteristics:
•1. Ulcer size \> 0.5 cm2 and \< 12 cm2 at least 2 cm from any other ulcer, and
•6. Patients with neuropathic or neuro-ischemic ulcers with adequate circulation to allow healing to the affected extremity as demonstrated by at least 2 of the following within 6 months of Visit 1:
•1. Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
•2. Absolute ankle pressure ≥ 70 mm Hg, or
+3 more criteria

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Patient participating in an interventional clinical trial within 1 month of Visit 1
•2. Currently receiving radiation to target area or chemotherapy
•3. Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
•4. Participant with active severe infection or osteomyelitis at the time of screening
•5. History of cancer within last 3 years, other than non-melanoma skin cancer
•6. Known or suspected malignancy of current study ulcer
•7. Use of adjunctive therapy within previous 30 days
•8. Currently receiving medication considered to be systemic glucocorticoids
•9. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral vascular intervention
+1 more criteria

Locations (6)

University of California - San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

University of Miami

Miami, Florida, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

October 14, 2020

Primary Completion Date

July 20, 2023

Completion Date

July 20, 2023

Last Updated

July 12, 2024

Enrollment

140

ACTUAL participants

Conditions

DiabetesDiabetic FootDiabetic Foot UlcerDiabetic Wound

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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C-myc Biomarker Study for Diabetic Foot Ulcers

Inclusion Criteria

Exclusion Criteria

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