CompletedPhase 2

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

United States5 participantsStarted 2010-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 8 week treatment period

Trial details

NCT IDNCT01138436

SponsorSkingenix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

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