A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

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 Venous Leg Ulcers

This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. 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 (7 subjects per treatment arm).

Study Overview

• Status: Completed
• Conditions: Ulcers
• Intervention / Treatment: Drug: MEBO Wound Ointment (MEBO); Procedure: Standard of Care

Detailed Description

To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. 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 (7 subjects per treatment arm).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Castro Valley, California, United States, 94546
      • Center for Clinical Research, Inc.
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Able and willing to provide informed consent.
3. Able and willing to comply with protocol visits and procedures.
4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.

Exclusion Criteria:

1. Ulcer of a non-venous hypertensive pathophysiology.
2. Known or suspected allergy to any of the components of MEBO.
3. Malignancy on target ulcer limb.
4. Received another investigational device or drug within 30 days of enrollment.
5. Non-compliance in the screening or run-in period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEBO Wound Ointment (MEBO); Topical application once a day	Drug: MEBO Wound Ointment (MEBO); Topical application once a day; Other Names: MEBO
Active Comparator: Standard of Care; Application of Profore multilayer compression bandage system	Procedure: Standard of Care; Application of Profore multilayer compression bandage system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of complete healing of the target ulcer within the 8-week treatment period.	8 week treatment period

Collaborators and Investigators

• Sponsor: Skingenix, Inc.
• Investigators: Study Chair: Robert Kirsner, MD, PhD, University of Miami

Study record dates

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 4, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimated): June 7, 2010

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Venous Leg Ulcers, VLU
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: MEBO-VSU-PII-001 v2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO