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

Skingenix, Inc.75 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, multi-center 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 Ointment (MEBO)DRUG

Topical application twice a day

Standard of CareOTHER

Topical application twice a day

Eligibility

Sex: ALLMin age: 18 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 (9)

HOPE Research Institute

Phoenix, Arizona, United States

Center for Clinical Research, Inc.

Castro Valley, California, United States

ILD Consulting, Inc.

Encinitas, California, United States

Outcomes

Primary Outcomes

The incidence of complete healing of the target ulcer.

Time frame: 8 week treatment period

Secondary Outcomes

Time required to achieve complete healing (days).

Time frame: 8 week treatment period

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

Time frame: 8 week treatment period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.