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

Skingenix, Inc.7 enrolled

Overview

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcers

Interventions

MEBO Wound OintmentDRUG

Topical application twice daily

Standard of Care (sterile saline moistened gauze)PROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (2)

Blume Podiatry Group, P.C.

New Haven, Connecticut, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

The incidence of complete healing of the target ulcer.

Time frame: 8 weeks of treatment period

Secondary Outcomes

Time required to achieve complete healing (days).

Time frame: 8 weeks treatment period

Absolute and percentage change in ulcer surface area from baseline to endpoint.

Time frame: 8 weeks treatment period

Data from ClinicalTrials.gov

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