A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
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
1 other identifier
interventional
7
1 country
2
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).
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 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 28, 2010
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of complete healing of the target ulcer.
8 weeks of treatment period
Secondary Outcomes (2)
Time required to achieve complete healing (days).
8 weeks treatment period
Absolute and percentage change in ulcer surface area from baseline to endpoint.
8 weeks treatment period
Study Arms (2)
MEBO Wound Ointment
EXPERIMENTALTopical application twice daily
Standard of Care (sterile saline moistened gauze)
ACTIVE COMPARATORTopical application twice daily
Interventions
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
- Target ulcer duration of ≥4 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skingenix, Inc.lead
Study Sites (2)
Blume Podiatry Group, P.C.
New Haven, Connecticut, 06515, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert S 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 28, 2010
First Posted
June 30, 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