A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
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
1 other identifier
interventional
5
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2010
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 6, 2025
November 1, 2025
11 months
June 4, 2010
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of complete healing of the target ulcer within the 8-week treatment period.
8 week treatment period
Study Arms (2)
MEBO Wound Ointment (MEBO)
EXPERIMENTALTopical application once a day
Standard of Care
ACTIVE COMPARATORApplication of Profore multilayer compression bandage system
Interventions
Topical application once a day
Application of Profore multilayer compression bandage system
Eligibility Criteria
You may qualify if:
- Male or female ≥18 years of age.
- Able and willing to provide informed consent.
- Able and willing to comply with protocol visits and procedures.
- A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.
You may not qualify if:
- Ulcer of a non-venous hypertensive pathophysiology.
- Known or suspected allergy to any of the components of MEBO.
- Malignancy on target ulcer limb.
- Received another investigational device or drug within 30 days of enrollment.
- Non-compliance in the screening or run-in period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skingenix, Inc.lead
Study Sites (2)
Center for Clinical Research, Inc.
Castro Valley, California, 94546, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Kirsner, MD, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 7, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share