NCT01154374

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Skingenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	MEBO Wound Ointment	Topical application twice daily
PROCEDURE	Standard of Care (sterile saline moistened gauze)

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-06-30
• Last updated: 2025-11-06

Locations

2 sites across 1 country: United States