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

NCT01070433 | Completed Phase 2

• 1 other identifier: MEBO-DFU-PII-001 v. 4.0
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic Foot Ulcers (DFUs)

Outcome Measures

Primary Outcomes (1)

• The incidence of complete healing of the target ulcer.

  8 week treatment period

Secondary Outcomes (2)

• Time required to achieve complete healing (days).

  8 week treatment period

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

  8 week treatment period

Study Arms (2)

MEBO Wound Ointment (MEBO)

EXPERIMENTAL

Topical application twice a day

Drug: MEBO Wound Ointment (MEBO)

Standard of Care

ACTIVE COMPARATOR

Topical application twice a day

Other: Standard of Care

Interventions

MEBO Wound Ointment (MEBO) DRUG

Topical application twice a day

Also known as: MEBO

MEBO Wound Ointment (MEBO)

Standard of Care OTHER

Topical application twice a day

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skingenix, Inc.: lead

Study Sites (9)

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

Location

ILD Consulting, Inc.

Encinitas, California, 92024, United States

Location

Sacramento Foot and Ankle Center

Fair Oaks, California, 95628, United States

Location

Valley Vascular Surgery Associates

Fresno, California, 93720, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90010, United States

Location

Advanced Foot and Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Complete Family Foot Care

McAllen, Texas, 78501, United States

Location

Endeavor Clinical Trials, San Antonio Podiatry Associates

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert S Kirsner, MD, PhD

  University of Miami

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 18, 2010
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)