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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070433
First Posted: February 18, 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
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Condition Intervention Phase
Diabetic Foot Ulcers Drug: MEBO Wound Ointment (MEBO) Other: 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, 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

Resource links provided by NLM:


Further study details as provided by Skingenix, Inc.:

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

Secondary Outcome 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 ]

Enrollment: 75
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEBO Wound Ointment (MEBO)
Topical application twice a day
Drug: MEBO Wound Ointment (MEBO)
Topical application twice a day
Other Name: MEBO
Active Comparator: Standard of Care
Topical application twice a day
Other: Standard of Care
Topical application twice a day

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  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): NCT01070433


Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85032
United States, California
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
ILD Consulting, Inc.
Encinitas, California, United States, 92024
Sacramento Foot and Ankle Center
Fair Oaks, California, United States, 95628
Valley Vascular Surgery Associates
Fresno, California, United States, 93720
Foot and Ankle Clinic
Los Angeles, California, United States, 90010
United States, Nevada
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States, 89119
United States, Texas
Complete Family Foot Care
McAllen, Texas, United States, 78501
Endeavor Clinical Trials, San Antonio Podiatry Associates
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Skingenix, Inc.
Investigators
Study Chair: Robert S Kirsner, MD, PhD University of Miami
  More Information

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01070433     History of Changes
Other Study ID Numbers: MEBO-DFU-PII-001 v. 4.0
First Submitted: February 16, 2010
First Posted: February 18, 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.:
Diabetic Foot Ulcers (DFUs)

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases