Trial | NCT01154374  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    7
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.
Study Started
Nov 30
2010
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Apr 26
2019

Drug MEBO Wound Ointment

Topical application twice daily

Procedure Standard of Care (sterile saline moistened gauze)

MEBO Wound Ointment Experimental

Topical application twice daily

Standard of Care (sterile saline moistened gauze) Active Comparator

Topical application twice daily

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
No Results Posted