Trial record 2 of 79 for:
cmyc
C-myc Biomarker Study for Diabetic Foot Ulcers
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| ClinicalTrials.gov Identifier: NCT04591691 |
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Recruitment Status :
Recruiting
First Posted : October 19, 2020
Last Update Posted : March 31, 2023
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Sponsor:
University of Michigan
Collaborators:
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
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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.
| Condition or disease |
|---|
| Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound |
| Study Type : | Observational |
| Estimated Enrollment : | 213 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 : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 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
Wound edge issue specimens are collected from the wound edge at Week 0 and, if clinically indicated, at Week 4 of the study. Investigators sample full thickness skin of a wound edge that includes epidermis and dermis.
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
Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
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Foot ulcer of diabetic etiology, with all of the following characteristics:
- Ulcer size > 0.5 cm2 and < 12 cm2 at least 2 cm from any other ulcer, and
- Ulcer with Wagner grade 1 or 2 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
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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:
- Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
- Absolute ankle pressure ≥ 70 mm Hg, or
- Toe pressure ≥ 40 mmHg, or
- TcPO2 ≥ 40 mmHg
- 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:
- Patient participating in an interventional clinical trial within 1 month of Visit 1
- Currently receiving radiation to target area or chemotherapy
- Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
- Participant with active severe infection or osteomyelitis at the time of screening
- History of cancer within last 3 years, other than non-melanoma skin cancer
- Known or suspected malignancy of current study ulcer
- Use of adjunctive therapy within previous 30 days
- Currently receiving medication considered to be systemic glucocorticoids
- Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral vascular intervention
- 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 ClinicalTrials.gov identifier (NCT number): NCT04591691
Contacts
| Contact: Katy Clark | 734-615-6767 | DFC-DCC-PM@umich.edu | |
| Contact: Tanvi Naik | 805-391-6777 | DFC-DCC-PM@umich.edu |
Locations
| United States, California | |
| University of California - San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Onorio Antonucci 415-353-4379 onorio.antonucci@ucsf.edu | |
| Principal Investigator: Michael Conte, MD | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Shannon Meyer smeyer72@stanford.edu | |
| Principal Investigator: Geoffrey Gurtner, MD, FACS | |
| United States, Florida | |
| University of Miami | Active, not recruiting |
| Miami, Florida, United States, 33126 | |
| United States, Indiana | |
| Indiana University Health | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Bryce Hockman 317-278-2715 bbhockma@iu.edu | |
| Contact: Henry Ludwig 317-504-5785 hbludwig@iu.edu | |
| Principal Investigator: Chandan K Sen, PhD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Aaron Burant 734-615-0552 aburant@med.umich.edu | |
| Principal Investigator: Rodica Pop-Busui, MD, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Active, not recruiting |
| Pittsburgh, Pennsylvania, United States, 25261 | |
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)
Investigators
| Principal Investigator: | Marjana Tomic-Canic | University of Miami |
| Responsible Party: | Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan |
| ClinicalTrials.gov 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: | March 31, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
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biomarker C-myc phosphorylated glucocorticoid receptor DFC Diabetic Foot Consortium |
Additional relevant MeSH terms:
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Diabetic Foot Foot Ulcer 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 |