Back to resultsA Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
Primary Purpose
Diabetic Foot Ulcers
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEBO Wound Ointment
Standard of Care (sterile saline moistened gauze)
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
- Blume Podiatry Group, P.C.
- Boston University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MEBO Wound Ointment
Standard of Care (sterile saline moistened gauze)
Arm Description
Topical application twice daily
Topical application twice daily
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
NCT01154374
Brief Title
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
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 Diabetic Foot 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
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, two-center pilot 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
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEBO Wound Ointment
Arm Type
Experimental
Arm Description
Topical application twice daily
Arm Title
Standard of Care (sterile saline moistened gauze)
Arm Type
Active Comparator
Arm Description
Topical application twice daily
Intervention Type
Drug
Intervention Name(s)
MEBO Wound Ointment
Intervention Description
Topical application twice daily
Intervention Type
Procedure
Intervention Name(s)
Standard of Care (sterile saline moistened gauze)
Primary Outcome Measure Information:
Title
The incidence of complete healing of the target ulcer.
Time Frame
8 weeks of treatment period
Secondary Outcome Measure Information:
Title
Time required to achieve complete healing (days).
Time Frame
8 weeks treatment period
Title
Absolute and percentage change in ulcer surface area from baseline to endpoint.
Time Frame
8 weeks treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 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
Blume Podiatry Group, P.C.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
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