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

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 Venous Leg Ulcers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01138436

Enrollment

Registered

2010-06-07

Start date

2010-11-30

Completion date

2011-10-31

Last updated

2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcers

Keywords

Venous Leg Ulcers, VLU

Brief 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).

Detailed description

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).

Interventions

DRUGMEBO Wound Ointment (MEBO)

Topical application once a day

PROCEDUREStandard of Care

Application of Profore multilayer compression bandage system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of complete healing of the target ulcer within the 8-week treatment period.	8 week treatment period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026