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| ID | Type | Description | Link |
|---|---|---|---|
| 1U24DK122927-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| Stanford University | OTHER |
| University of Miami | OTHER |
| University of Pittsburgh |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 weeks |
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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.
Foot ulcer of diabetic etiology, with all of the following characteristics:
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:
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:
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Adult Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer
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| Name | Affiliation | Role |
|---|---|---|
| Marjana Tomic-Canic | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
| University of California, San Francisco | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
| Stanford |
| California |
| 94305 |
| United States |
| University of Miami | Miami | Florida | 33126 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 25261 | United States |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |