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

NCT ID: NCT01070433

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEBO Wound Ointment (MEBO)

Topical application twice a day

Group Type EXPERIMENTAL

MEBO Wound Ointment (MEBO)

Intervention Type DRUG

Topical application twice a day

Standard of Care

Topical application twice a day

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Topical application twice a day

Interventions

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MEBO Wound Ointment (MEBO)

Topical application twice a day

Intervention Type DRUG

Standard of Care

Topical application twice a day

Intervention Type OTHER

Other Intervention Names

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MEBO

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Skingenix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert S Kirsner, MD, PhD

Role: STUDY_CHAIR

University of Miami

Locations

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HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Center for Clinical Research, Inc.

Castro Valley, California, United States

Site Status

ILD Consulting, Inc.

Encinitas, California, United States

Site Status

Sacramento Foot and Ankle Center

Fair Oaks, California, United States

Site Status

Valley Vascular Surgery Associates

Fresno, California, United States

Site Status

Foot and Ankle Clinic

Los Angeles, California, United States

Site Status

Advanced Foot and Ankle Center

Las Vegas, Nevada, United States

Site Status

Complete Family Foot Care

McAllen, Texas, United States

Site Status

Endeavor Clinical Trials, San Antonio Podiatry Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MEBO-DFU-PII-001 v. 4.0

Identifier Type: -

Identifier Source: org_study_id

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