A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcers
- Interventions
- Drug: MEBO Wound Ointment (MEBO)Other: Standard of Care
- Registration Number
- NCT01070433
- Lead Sponsor
- Skingenix, Inc.
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MEBO Wound Ointment (MEBO) MEBO Wound Ointment (MEBO) Topical application twice a day Standard of Care Standard of Care Topical application twice a day
- Primary Outcome Measures
Name Time Method The incidence of complete healing of the target ulcer. 8 week treatment period
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- 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
Sacramento Foot and Ankle Center
🇺🇸Fair Oaks, California, United States
Valley Vascular Surgery Associates
🇺🇸Fresno, California, United States
Foot and Ankle Clinic
🇺🇸Los Angeles, California, United States
Advanced Foot and Ankle Center
🇺🇸Las Vegas, Nevada, United States
Complete Family Foot Care
🇺🇸McAllen, Texas, United States
Endeavor Clinical Trials, San Antonio Podiatry Associates
🇺🇸San Antonio, Texas, United States
HOPE Research Institute🇺🇸Phoenix, Arizona, United States