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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Drug: MEBO Wound Ointment (MEBO); Other: Standard of Care

• Registration Number: NCT01070433
• 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, 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.

Study Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2012-09
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Disposition First Submitted: 2015-05-18
• Disposition First Submitted QC: 2015-05-18
• Disposition First Posted: 2015-06-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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)	MEBO Wound Ointment (MEBO)	Topical application twice a day
Standard of Care	Standard of Care	Topical application twice a day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time required to achieve complete healing (days).	8 week treatment period
Absolute and percentage change in ulcer surface area from baseline to endpoint.	8 week treatment period

Trial Locations

Locations (9)

Valley Vascular Surgery Associates; 🇺🇸 Fresno, California, United States

Foot and Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Advanced Foot and Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

Endeavor Clinical Trials, San Antonio Podiatry Associates; 🇺🇸 San Antonio, Texas, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

ILD Consulting, Inc.; 🇺🇸 Encinitas, California, United States

Center for Clinical Research, Inc.; 🇺🇸 Castro Valley, California, United States

Sacramento Foot and Ankle Center; 🇺🇸 Fair Oaks, California, United States

Complete Family Foot Care; 🇺🇸 McAllen, Texas, United States