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NCT Number: NCT01138436

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

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).

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Key information

Conditions

Ulcers Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Clinical Research, Inc., Castro Valley, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Ulcer of a non-venous hypertensive pathophysiology.
  • Known or suspected allergy to any of the components of MEBO.
  • Malignancy on target ulcer limb.
  • Received another investigational device or drug within 30 days of enrollment.
  • Non-compliance in the screening or run-in period.

Treatment and study plan

MEBO Wound Ointment (MEBO)

Drug

Topical application once a day

Other names: MEBO

Standard of care

Procedure

Application of Profore multilayer compression bandage system

Primary outcomes

  1. Incidence of complete healing of the target ulcer within the 8-week treatment period.

    Time frame: 8 week treatment period

Sponsors and collaborators

Lead sponsor

Skingenix, Inc.

Industry

Registry information

Official study 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 Venous Leg Ulcers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2010
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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