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The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microvessel Ultrasound Imaging for Chronic Ulcers | Experimental | Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microvessel Ultrasound Examination | Diagnostic Test | Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin |
| Measure | Description | Time Frame |
|---|---|---|
| Microvessel imaging | Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael R Moynagh, MD | Contact | 507-266-4755 | moynagh.michael@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Moynagh, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2024 | Jan 2, 2026 | ICF_000.pdf |
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| Skin Biopsy | Procedure | Dermatology will remove a small piece of skin from the affected ulcer area and control skin |
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