Status:
COMPLETED
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
Lead Sponsor:
Skingenix, Inc.
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
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 ra...
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
- Target ulcer duration of ≥4 weeks
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01154374
Start Date
November 1 2010
End Date
October 1 2011
Last Update
November 6 2025
Active Locations (2)
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1
Blume Podiatry Group, P.C.
New Haven, Connecticut, United States, 06515
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118