Clinical Trial: A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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).
Detailed Summary: 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.
Sponsor: Skingenix, Inc.
Current Primary Outcome: The incidence of complete healing of the target ulcer. [ Time Frame: 8 week treatment period ]
Original Primary Outcome: The incidence of complete healing of the target ulcer. [ Time Frame: 12 week treatment period ]
Current Secondary Outcome:
- Time required to achieve complete healing (days). [ Time Frame: 8 week treatment period ]
- Absolute and percentage change in ulcer surface area from baseline to endpoint. [ Time Frame: 8 week treatment period ]
Original Secondary Outcome:
- Time required to achieve complete healing (days). [ Time Frame: 12 week treatment period ]
- Absolute and percentage change in ulcer surface area from baseline to endpoint. [ Time Frame: 12 week treatment period ]
Information By: Skingenix, Inc.
Dates:
Date Received: February 16, 2010
Date Started: September 2012
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017
