C-myc Biomarker Study for Diabetic Foot Ulcers

NCT ID: NCT04591691

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2023-07-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Cathie Spino, ScD

Research Professor of Biostatistics, SABER Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marjana Tomic-Canic

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of California - San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

University of Miami

Miami, Florida, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

1U24DK122927-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00168547

Identifier Type: -

Identifier Source: org_study_id