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

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ClinicalTrials.gov Identifier: NCT01154374
Recruitment Status : Completed
First Posted : June 30, 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 Procedure: Standard of Care (sterile saline moistened gauze) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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 Diabetic Foot Ulcers
Study Start Date : November 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MEBO Wound Ointment
Topical application twice daily
Drug: MEBO Wound Ointment
Topical application twice daily
Active Comparator: Standard of Care (sterile saline moistened gauze)
Topical application twice daily
Procedure: Standard of Care (sterile saline moistened gauze)



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (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

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): 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

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01154374     History of Changes
Other Study ID Numbers: MEBO-DFU-PILOTII-001
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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