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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138436
First Posted: June 7, 2010
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Skingenix, Inc.
  Purpose
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).

Condition Intervention Phase
Ulcers Drug: MEBO Wound Ointment (MEBO) Procedure: Standard of Care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Skingenix, Inc.:

Primary Outcome Measures:
  • Incidence of complete healing of the target ulcer within the 8-week treatment period. [ Time Frame: 8 week treatment period ]

Enrollment: 5
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEBO Wound Ointment (MEBO)
Topical application once a day
Drug: MEBO Wound Ointment (MEBO)
Topical application once a day
Other Name: MEBO
Active Comparator: Standard of Care
Application of Profore multilayer compression bandage system
Procedure: Standard of Care
Application of Profore multilayer compression bandage system

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138436


Locations
United States, California
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
Skingenix, Inc.
Investigators
Study Chair: Robert Kirsner, MD, PhD University of Miami
  More Information

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01138436     History of Changes
Other Study ID Numbers: MEBO-VSU-PII-001 v2.0
First Submitted: June 4, 2010
First Posted: June 7, 2010
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Skingenix, Inc.:
Venous Leg Ulcers, VLU

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases