A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
NCT01138436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-11-06
Summary
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).
Conditions
- Ulcers
Interventions
- DRUG
-
MEBO Wound Ointment (MEBO)
Topical application once a day
- PROCEDURE
-
Standard of Care
Application of Profore multilayer compression bandage system
Sponsors & Collaborators
-
Skingenix, Inc.
lead INDUSTRY
Principal Investigators
-
Robert Kirsner, MD, PhD · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2011-10-31
- Completion
- 2011-10-31
Countries
- United States
Study Locations
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