Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Michael Conte, MD
Photo of Michael Conte
Michael Conte

Description

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. 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

Keywords

Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound biomarker C-myc phosphorylated glucocorticoid receptor DFC Diabetic Foot Consortium Foot Ulcer Ulcer

Eligibility

You can join if…

Open to people ages 18 years and up

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. Previous diagnosis of Type 1 or Type 2 diabetes
  5. Foot ulcer of diabetic etiology, with all of the following characteristics:
  6. Ulcer size > 1 cm2and < 10 cm2 at least 2 cm from any other ulcer, and
  7. Ulcer duration of > 4 weeks, unresponsive to standard wound care with off-loading and debridement over the preceding 4 weeks with < 50% healing, and
  8. Ulcer with Wagner grade 1 or 2 (see Table 5.1.1). In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
  9. Glycated hemoglobin (HbA1c) < 12% within 3 months prior to Visit 1 (first tissue collection of foot ulcer)
  10. Patients with neuropathic or neuro-ischemic ulcers with adequate circulation to allow healing to the affected extremity as demonstrated by at least 2of the following:
  11. Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
  12. Absolute ankle pressure ≥ 70 mm Hg, or
  13. Toe pressure ≥ 40 mmHg, or
  14. TcPO2 ≥ 40 mmHg

You CAN'T join if...

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 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 (Refer to Sec 6.37.1)
  5. History of cancer within last 5 years, other than non-melanoma skin cancer
  6. Known or suspected malignancy of current study ulcer
  7. Diagnosis of autoimmune connective tissue disease (see Table 5.2.1)
  8. Use of adjunctive therapy within previous 30 days (see Table 5.2.2)
  9. Currently receiving medication considered to be immune system modulators (see Table 5.2.3)
  10. . On kidney dialysis or post-kidney transplant.
  11. . Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral vascular intervention
  12. . Pregnant or lactating women
  13. . 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

Locations

  • University of California - San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSF

  • Michael Conte, MD
    Professor, Surgery. Authored (or co-authored) 257 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT04591691
Study Type
Observational
Last Updated