Back to resultsA Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
Primary Purpose
Ulcers
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEBO Wound Ointment (MEBO)
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Ulcers focused on measuring Venous Leg Ulcers, VLU
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Center for Clinical Research, Inc.
- University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MEBO Wound Ointment (MEBO)
Standard of Care
Arm Description
Topical application once a day
Application of Profore multilayer compression bandage system
Outcomes
Primary Outcome Measures
Incidence of complete healing of the target ulcer within the 8-week treatment period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01138436
Brief Title
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skingenix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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 MEBO or SOC (7 subjects per treatment arm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers
Keywords
Venous Leg Ulcers, VLU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEBO Wound Ointment (MEBO)
Arm Type
Experimental
Arm Description
Topical application once a day
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Application of Profore multilayer compression bandage system
Intervention Type
Drug
Intervention Name(s)
MEBO Wound Ointment (MEBO)
Other Intervention Name(s)
MEBO
Intervention Description
Topical application once a day
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Application of Profore multilayer compression bandage system
Primary Outcome Measure Information:
Title
Incidence of complete healing of the target ulcer within the 8-week treatment period.
Time Frame
8 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
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