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

April 19, 2019 updated by: Skingenix, Inc.

A Phase II, Randomized, Controlled, Two-Center Pilot 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, 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 Type

Interventional

Enrollment (Actual)

7

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
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • Blume Podiatry Group, P.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine

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 to 77 years (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
Topical application twice daily
Drug: MEBO Wound Ointment
Topical application twice daily
Active Comparator: Standard of Care (sterile saline moistened gauze)
Topical application twice daily
Procedure: Standard of Care (sterile saline moistened gauze)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 30, 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-PILOTII-001

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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