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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01070433
First received: February 16, 2010
Last updated: January 6, 2014
Last verified: January 2014

February 16, 2010
January 6, 2014
September 2012
September 2013   (final data collection date for primary outcome measure)
The incidence of complete healing of the target ulcer. [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
The incidence of complete healing of the target ulcer. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070433 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time required to achieve complete healing (days). [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
  • Absolute and percentage change in ulcer surface area from baseline to endpoint. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
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

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, 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.

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
  • Experimental: MEBO Wound Ointment (MEBO)
    Topical application twice a day
    Intervention: Drug: MEBO Wound Ointment (MEBO)
  • Active Comparator: Standard of Care
    Topical application twice a day
    Intervention: Procedure: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2013
September 2013   (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 and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070433
MEBO-DFU-PII-001 v. 4.0
No
Skingenix, Inc.
Skingenix, Inc.
Not Provided
Study Chair: Robert S Kirsner, MD, PhD University of Miami
Skingenix, Inc.
January 2014

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