C-myc Biomarker Study for Diabetic Foot Ulcers

Not Recruiting

Trial ID: NCT04591691


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.

Official Title

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

Stanford Investigator(s)


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)

   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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305