A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2017 |
| Start Date: | November 2010 |
| End Date: | October 2011 |
A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Venous Leg Ulcers
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).
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).
Inclusion Criteria:
1. Male or female ≥18 years of age.
2. Able and willing to provide informed consent.
3. Able and willing to comply with protocol visits and procedures.
4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.
Exclusion Criteria:
1. Ulcer of a non-venous hypertensive pathophysiology.
2. Known or suspected allergy to any of the components of MEBO.
3. Malignancy on target ulcer limb.
4. Received another investigational device or drug within 30 days of enrollment.
5. Non-compliance in the screening or run-in period.
We found this trial at
2
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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