Back to resultsA Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot 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 Diabetic Foot Ulcers focused on measuring Diabetic Foot Ulcers (DFUs)
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
- Target ulcer duration of ≥4 weeks
Exclusion Criteria:
- Ulcer of a non-diabetic pathophysiology
- Known or suspected allergies to any of the components of MEBO
- Malignancy on target ulcer foot
- Non-compliance in the screening or run-in period
Sites / Locations
- HOPE Research Institute
- Center for Clinical Research, Inc.
- ILD Consulting, Inc.
- Sacramento Foot and Ankle Center
- Valley Vascular Surgery Associates
- Foot and Ankle Clinic
- Advanced Foot and Ankle Center
- Complete Family Foot Care
- Endeavor Clinical Trials, San Antonio Podiatry Associates
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 twice a day
Topical application twice a day
Outcomes
Primary Outcome Measures
The incidence of complete healing of the target ulcer.
Secondary Outcome Measures
Time required to achieve complete healing (days).
Absolute and percentage change in ulcer surface area from baseline to endpoint.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01070433
Brief Title
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
Official Title
A Phase II, Randomized, Controlled, Multi-Center Study of the Safety and Efficacy of Topically Applied MEBO Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (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
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
Detailed Description
This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetic Foot Ulcers (DFUs)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEBO Wound Ointment (MEBO)
Arm Type
Experimental
Arm Description
Topical application twice a day
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Topical application twice a day
Intervention Type
Drug
Intervention Name(s)
MEBO Wound Ointment (MEBO)
Other Intervention Name(s)
MEBO
Intervention Description
Topical application twice a day
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Topical application twice a day
Primary Outcome Measure Information:
Title
The incidence of complete healing of the target ulcer.
Time Frame
8 week treatment period
Secondary Outcome Measure Information:
Title
Time required to achieve complete healing (days).
Time Frame
8 week treatment period
Title
Absolute and percentage change in ulcer surface area from baseline to endpoint.
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
Target ulcer duration of ≥4 weeks
Exclusion Criteria:
Ulcer of a non-diabetic pathophysiology
Known or suspected allergies to any of the components of MEBO
Malignancy on target ulcer foot
Non-compliance in the screening or run-in period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Kirsner, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Study Chair
Facility Information:
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
ILD Consulting, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Sacramento Foot and Ankle Center
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Valley Vascular Surgery Associates
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
Advanced Foot and Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Complete Family Foot Care
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Endeavor Clinical Trials, San Antonio Podiatry Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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 Diabetic Foot Ulcers
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