A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

Phase 2

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Drug: MEBO Wound Ointment; Procedure: Standard of Care (sterile saline moistened gauze)

• Registration Number: NCT01154374
• Lead Sponsor: Skingenix, Inc.

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.

Study Timeline

• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-30
• Study Start: 2010-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2013-07-19
• Disposition First Submitted QC: 2013-07-19
• Disposition First Posted: 2013-07-23
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEBO Wound Ointment	MEBO Wound Ointment	Topical application twice daily
Standard of Care (sterile saline moistened gauze)	Standard of Care (sterile saline moistened gauze)	Topical application twice daily

Primary Outcome Measures

Name	Time	Method
The incidence of complete healing of the target ulcer.	8 weeks of treatment period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Blume Podiatry Group, P.C.; 🇺🇸 New Haven, Connecticut, United States