CompletedPhase 2

A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

United States7 participantsStarted 2010-11

Plain-language 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).

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Target ulcer duration of ≥4 weeks Exclusion Criteria: * Ulcer of a non-diabetic pathophysiology * Known or suspected allergies to any of the components of MEBO * Malignancy on target ulcer foot * Non-compliance in the screening or run-in period

What they're measuring

The incidence of complete healing of the target ulcer.

Timeframe: 8 weeks of treatment period

Trial details

NCT IDNCT01154374

SponsorSkingenix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

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