C-myc Biomarker Study for Diabetic Foot Ulcers

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04591691

Collaborator

Indiana University (Other), Stanford University (Other), University of Miami (Other), University of Pittsburgh (Other), University of California, San Francisco (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

213

Enrollment

Locations

38.5

Anticipated Duration (Months)

35.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound

Study Design

Study Type:

Observational

Anticipated Enrollment :

213 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 14, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - San Francisco	San Francisco	California	United States	94143
2	Stanford University	Stanford	California	United States	94305
3	University of Miami	Miami	Florida	United States	33126
4	Indiana University Health	Indianapolis	Indiana	United States	46202
5	University of Michigan	Ann Arbor	Michigan	United States	48109
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	25261