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

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ClinicalTrials.gov Identifier: NCT01070433
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: MEBO Wound Ointment (MEBO) Other: Standard of Care Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Time required to achieve complete healing (days). [ Time Frame: 8 week treatment period ]
  2. Absolute and percentage change in ulcer surface area from baseline to endpoint. [ Time Frame: 8 week treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01070433     History of Changes
Other Study ID Numbers: MEBO-DFU-PII-001 v. 4.0
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
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