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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154374
• Other study ID #: MEBO-DFU-PILOTII-001
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2019
• Source: Skingenix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• MEBO Wound Ointment
Topical application twice daily

Procedure:
• Standard of Care (sterile saline moistened gauze)

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Blume Podiatry Group, P.C.	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Skingenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complete healing of the target ulcer.		8 weeks of treatment period
Secondary	Time required to achieve complete healing (days).		8 weeks treatment period
Secondary	Absolute and percentage change in ulcer surface area from baseline to endpoint.		8 weeks treatment period