C-myc Biomarker Study for Diabetic Foot Ulcers

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Wound

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Florida
    • Miami, Florida, United States, 33126
      • University of Miami
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 25261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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
   2. Ulcer with Wagner grade 1 or 2 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.

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. Toe pressure ≥ 40 mmHg, or
   4. TcPO2 ≥ 40 mmHg
7. Willingness to comply with standard of care which includes an initial surgical debridement of the wound.

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
10. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Miami; University of Pittsburgh; University of California, San Francisco; Stanford University; Indiana University
• Investigators: Principal Investigator: Marjana Tomic-Canic, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: biomarker; C-myc; phosphorylated glucocorticoid receptor; DFC; Diabetic Foot Consortium
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: HUM00168547; 1U24DK122927-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No