C-myc Biomarker Study for Diabetic Foot Ulcers

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591691
• Other study ID #: HUM00168547
• Secondary ID: 1U24DK122927-01
• Status: Recruiting
• Start date: October 14, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: University of Michigan
• Contact: Katy Clark
• Phone: 734-615-6767
• Email: DFC-DCC-PM[@]umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Wound
• Foot Ulcer
• Ulcer

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California - San Francisco	San Francisco	California
United States	Stanford University	Stanford	California

Sponsors (7)

Lead Sponsor	Collaborator
University of Michigan	Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of California, San Francisco, University of Miami, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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