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The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEBO Wound Ointment (MEBO) | Experimental | Topical application twice a day |
|
| Standard of Care | Active Comparator | Topical application twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEBO Wound Ointment (MEBO) | Drug | Topical application twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of complete healing of the target ulcer. | 8 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time required to achieve complete healing (days). | 8 week treatment period | |
| Absolute and percentage change in ulcer surface area from baseline to endpoint. | 8 week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Kirsner, MD, PhD | University of Miami | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85032 | United States | ||
| Center for Clinical Research, Inc. |
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| Standard of Care | Other | Topical application twice a day |
|
| Castro Valley |
| California |
| 94546 |
| United States |
| ILD Consulting, Inc. | Encinitas | California | 92024 | United States |
| Sacramento Foot and Ankle Center | Fair Oaks | California | 95628 | United States |
| Valley Vascular Surgery Associates | Fresno | California | 93720 | United States |
| Foot and Ankle Clinic | Los Angeles | California | 90010 | United States |
| Advanced Foot and Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Complete Family Foot Care | McAllen | Texas | 78501 | United States |
| Endeavor Clinical Trials, San Antonio Podiatry Associates | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| 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 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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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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