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

Sponsor:	Skingenix, Inc.
Information provided by:	Skingenix, Inc.
ClinicalTrials.gov Identifier:	NCT01070433

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) Drug: Sterile Saline Gel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time required to achieve complete healing (days). [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
Absolute and percentage change in ulcer surface area from baseline to endpoint. [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	April 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MEBO Wound Ointment (MEBO)	Drug: MEBO Wound Ointment (MEBO) Topical application twice a day
Active Comparator: Sterile Saline Gel	Drug: Sterile Saline Gel 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 ≥2 months

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070433

Sponsors and Collaborators

Skingenix, Inc.

Investigators

Study Chair:

Robert S Kirsner, MD, PhD

University of Miami Miller School of Medicine

More Information

No publications provided

Responsible Party:	Jiayao Eric Wang, MD, CCRP, RAC, Senior Vice President, Skingenix, Inc.
ClinicalTrials.gov Identifier:	NCT01070433 History of Changes
Other Study ID Numbers:	MEBO-DFU-PII-001 v. 2.0
Study First Received:	February 16, 2010
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Skingenix, Inc.:

Diabetic Foot Ulcers (DFUs)

Additional relevant MeSH terms:

Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on February 09, 2012