Status:
COMPLETED
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
Lead Sponsor:
Skingenix, Inc.
Conditions:
Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01138436
Start Date
November 1 2010
End Date
October 1 2011
Last Update
November 6 2025
Active Locations (2)
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1
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136