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This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).
To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEBO Wound Ointment (MEBO) | Experimental | Topical application once a day |
|
| Standard of Care | Active Comparator | Application of Profore multilayer compression bandage system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEBO Wound Ointment (MEBO) | Drug | Topical application once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete healing of the target ulcer within the 8-week treatment period. | 8 week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kirsner, MD, PhD | University of Miami | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research, Inc. | Castro Valley | California | 94546 | United States | ||
| University of Miami Miller School of Medicine |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Procedure | Application of Profore multilayer compression bandage system |
|
| Miami |
| Florida |
| 33136 |
| United States |