A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. 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 (7 subjects per treatment arm).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Skingenix, Inc.

Criteria

Inclusion Criteria:

1. Male or female ≥18 years of age.

2. Able and willing to provide informed consent.

3. Able and willing to comply with protocol visits and procedures.

4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.

Exclusion Criteria:

1. Ulcer of a non-venous hypertensive pathophysiology.

2. Known or suspected allergy to any of the components of MEBO.

3. Malignancy on target ulcer limb.

4. Received another investigational device or drug within 30 days of enrollment.

5. Non-compliance in the screening or run-in period.