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

Status:	Completed
Conditions:	Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:	Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - 79
Updated:	1/12/2017
Start Date:	November 2010
End Date:	October 2011

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.

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

We found this trial at

sites

Boston University School of Medicine

72 East Concord Street
Boston, Massachusetts 02118

(617) 638-5300