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C-myc Biomarker Study for Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04591691
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : November 16, 2020
Indiana University
Stanford University
University of Miami
University of Pittsburgh
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Cathie Spino, ScD, University of Michigan

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. 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
Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound

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Study Type : Observational
Estimated Enrollment : 239 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 : October 14, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 12 weeks ]

Biospecimen Retention:   Samples Without DNA
Using a 3mm punch biopsy device, two adjacent tissue specimens are collected from the wound edge at Week 0 and Week 4 of the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer

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. Previous diagnosis of Type 1 or Type 2 diabetes
  5. Foot ulcer of diabetic etiology, with all of the following characteristics:

    1. Ulcer size > 1 cm2and < 10 cm2 at least 2 cm from any other ulcer, and
    2. Ulcer duration of > 4 weeks, unresponsive to standard wound care with off-loading and debridement over the preceding 4 weeks with < 50% healing, and
    3. 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.
  6. Glycated hemoglobin (HbA1c) < 12% within 3 months prior to Visit 1 (first tissue collection of foot ulcer)
  7. 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:

    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

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04591691

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Contact: Brandi Gizinski 7347633632
Contact: Jen Mawby 7347637810

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United States, California
University of California - San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Christina Kuhrau    415-353-4367   
Contact: Manveer Hundal    415-353-4379   
Principal Investigator: Michael Conte, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Shannon Meyer   
Principal Investigator: Geoffrey Gurtner, MD, FACS         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33126
Contact: Aliette Espinosa    305-689-3376   
Contact: Flor MacQuhae    305-689-3376   
Principal Investigator: Robert S Kirsner, MD, PhD         
United States, Indiana
Indiana University Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Mohnacky    317-278-2715   
Contact: Bindu Neupane Wagle    317-278-2715   
Principal Investigator: Chandan K Sen, PhD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jacob Reiss    734-763-0177   
Contact: Aaron Burant    734-615-0552   
Principal Investigator: Rodica Pop-Busui, MD, PhD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 25261
Contact: Center for Innovation and Restorative Medicine    412-641-8676      
Principal Investigator: J. Peter Rubin, MD, FACS         
Sponsors and Collaborators
University of Michigan
Indiana University
Stanford University
University of Miami
University of Pittsburgh
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Marjana Tomic-Canic University of Miami
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Responsible Party: Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan Identifier: NCT04591691    
Other Study ID Numbers: HUM00168547
1U24DK122927-01 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cathie Spino, ScD, University of Michigan:
phosphorylated glucocorticoid receptor
Diabetic Foot Consortium
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases