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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: MEBO Wound Ointment (MEBO)
    • Topical application twice a day
  • Active Comparator: Standard of Care
    • Topical application twice a day

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Skingenix, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert S Kirsner, MD, PhD, Study Chair, University of Miami

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