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NCT01070433 Clinical Trial

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

Diabetic Foot Ulcers Clinical Trial

Official title:
A Phase II, Randomized, Controlled, Multi-Center Study of the Safety and Efficacy of Topically Applied MEBO Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01070433
Other study ID # MEBO-DFU-PII-001 v. 4.0
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2012
Est. completion date December 2013

Study information
Verified date April 2019
Source Skingenix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MEBO Wound Ointment (MEBO)
Topical application twice a day
Other:
• Standard of Care
Topical application twice a day

Locations
Country Name City State
United States Center for Clinical Research, Inc. Castro Valley California
United States ILD Consulting, Inc. Encinitas California
United States Sacramento Foot and Ankle Center Fair Oaks California
United States Valley Vascular Surgery Associates Fresno California
United States Advanced Foot and Ankle Center Las Vegas Nevada
United States Foot and Ankle Clinic Los Angeles California
United States Complete Family Foot Care McAllen Texas
United States HOPE Research Institute Phoenix Arizona
United States Endeavor Clinical Trials, San Antonio Podiatry Associates San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Skingenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of complete healing of the target ulcer. 8 week treatment period
Secondary Time required to achieve complete healing (days). 8 week treatment period
Secondary Absolute and percentage change in ulcer surface area from baseline to endpoint. 8 week treatment period
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