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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01154374
First received: June 28, 2010
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  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)
Procedure: Standard of Care
 Phase 2

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, Two-Center Pilot 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:

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 weeks of treatment period ] [ Designated as safety issue: No ]

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

Enrollment: 7
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 twice a day
 Drug: MEBO Wound Ointment (MEBO)
Topical application twice a day
Active Comparator: Standard of Care (sterile saline moistened gauze)
Topical application twice a day
 Procedure: Standard of Care

Detailed Description:

This is a phase II, randomized, controlled, two-center pilot 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 to 79 Years
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 ≥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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154374

Locations
United States, Connecticut
Blume Podiatry Group, P.C.
New Haven, Connecticut, United States, 06515
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Skingenix, Inc.
Investigators
Study Chair: Robert S Kirsner, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01154374     History of Changes
Other Study ID Numbers: MEBO-DFU-PILOTII-001
Study First Received: June 28, 2010
Last Updated: June 5, 2013
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 June 18, 2013