Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

Phase 2

Completed

Brief Summary: This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.

Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.

Participation in the study can be up to 4½ months.

Recruitment & Eligibility

Inclusion Criteria

Participants included in the study must:

Have type 1 or type 2 diabetes mellitus.
Have problems with the nerves in their feet.
Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
Be able to apply study drug to their ulcer, or have a caregiver do it.
Be able to visit the doctor regularly during the 4½ month study.

Exclusion Criteria

Participants may not participate in the study if:

Their ulcer is caused by bad blood flow to their foot.
Their ulcer is infected.
They cannot wear a special boot during the study to take pressure off the ulcer.
They have certain other diseases, or are using certain types of drugs.

Primary Outcome Measures

Name	Time	Method
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.

Secondary Outcome Measures

Name	Time	Method
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.

Locations (63): Institute for Advanced Wound Care
🇺🇸
Montgomery, Alabama, United States
Palo Verde Foot and Ankle
🇺🇸
Bullhead City, Arizona, United States
Carl T. Hayden VA Medical Center
🇺🇸
Phoenix, Arizona, United States
Associated Foot & Ankle Specialists, LLC
🇺🇸
Phoenix, Arizona, United States
Aung Foot Health Clinics & Advanced Wound Care
🇺🇸
Tucson, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸
Tucson, Arizona, United States
Vertex Clinical Research
🇺🇸
Bakersfield, California, United States
Roy O. Kroeker, DPM
🇺🇸
Fresno, California, United States
Innovative Medical Technologies
🇺🇸
Los Angeles, California, United States
UCSD Wound Treatment and Research Center
🇺🇸
San Diego, California, United States
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Institute for Advanced Wound Care
🇺🇸Montgomery, Alabama, United States