C-myc Biomarker Study for Diabetic Foot Ulcers

NCT04591691 | Completed DMC

• 2 other identifiers: HUM001685471U24DK122927-01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Diabetes; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Wound

Keywords

biomarker; C-myc; phosphorylated glucocorticoid receptor; DFC; Diabetic Foot Consortium

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with complete wound healing by week 12, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements

  Up to 12 weeks

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

Adult Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or older.
• Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
• Foot ulcer of diabetic etiology, with all of the following characteristics:
• Ulcer size \> 0.5 cm2 and \< 12 cm2 at least 2 cm from any other ulcer, and
• 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:
• Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
• Absolute ankle pressure ≥ 70 mm Hg, or
• Toe pressure ≥ 40 mmHg, or
• TcPO2 ≥ 40 mmHg
• Willingness to comply with standard of care which includes an initial surgical debridement of the wound.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Patient participating in an interventional clinical trial within 1 month of Visit 1
• Currently receiving radiation to target area or chemotherapy
• Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
• Participant with active severe infection or osteomyelitis at the time of screening
• History of cancer within last 3 years, other than non-melanoma skin cancer
• Known or suspected malignancy of current study ulcer
• Use of adjunctive therapy within previous 30 days
• Currently receiving medication considered to be systemic glucocorticoids
• Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral vascular intervention
• Any history of concomitant medical 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
• Indiana University: collaborator
• Stanford University: collaborator
• University of Miami: collaborator
• University of Pittsburgh: collaborator
• University of California, San Francisco: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33126, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 25261, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Wound edge issue specimens are collected from the wound edge at Week 0 and, if clinically indicated, at Week 4 of the study. Investigators sample full thickness skin of a wound edge that includes epidermis and dermis.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Marjana Tomic-Canic

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Biostatistics, SABER Director

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: October 14, 2020
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

US (6)