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: July 23, 2013
Last verified: July 2013

June 28, 2010
July 23, 2013
November 2010
October 2011   (final data collection date for primary outcome measure)
The incidence of complete healing of the target ulcer. [ Time Frame: 8 weeks of treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154374 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
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

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot Ulcers
  • Drug: MEBO Wound Ointment (MEBO)
    Topical application twice a day
  • Procedure: Standard of Care (sterile saline moistened gauze)
  • Experimental: MEBO Wound Ointment (MEBO)
    Topical application twice a day
    Intervention: Drug: MEBO Wound Ointment (MEBO)
  • Active Comparator: Standard of Care (sterile saline moistened gauze)
    Topical application twice a day
    Intervention: Procedure: Standard of Care (sterile saline moistened gauze)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01154374
MEBO-DFU-PILOTII-001
Not Provided
Skingenix, Inc.
Skingenix, Inc.
Not Provided
Study Chair: Robert S Kirsner, MD, PhD University of Miami
Skingenix, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP