C-myc Biomarker Study for Diabetic Foot Ulcers

University of Michigan

Status: Completed

Conditions: Diabetic Foot; Diabetes; Diabetic Wound; Diabetic Foot Ulcer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04591691

1U24DK122927-01 (U.S. NIH Grant/Contract)

HUM00168547

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
   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