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

April 19, 2019 updated by: Skingenix, Inc.

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

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • HOPE Research Institute
    • California
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research, Inc.
      • Encinitas, California, United States, 92024
        • ILD Consulting, Inc.
      • Fair Oaks, California, United States, 95628
        • Sacramento Foot and Ankle Center
      • Fresno, California, United States, 93720
        • Valley Vascular Surgery Associates
      • Los Angeles, California, United States, 90010
        • Foot and Ankle Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advanced Foot and Ankle Center
    • Texas
      • McAllen, Texas, United States, 78501
        • Complete Family Foot Care
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, San Antonio Podiatry Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEBO Wound Ointment (MEBO)
Topical application twice a day
Drug: MEBO Wound Ointment (MEBO)
Topical application twice a day
Other Names:
  • MEBO
Active Comparator: Standard of Care
Topical application twice a day
Other: Standard of Care
Topical application twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of complete healing of the target ulcer.
Time Frame: 8 week treatment period
8 week treatment period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skingenix, Inc.

Investigators

  • Study Chair: Robert S Kirsner, MD, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEBO-DFU-PII-001 v. 4.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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