Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

Phase 2

Terminated

Brief Summary: This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors.

Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). 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 a large ulcer or multiple ulcers 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 an off-loading device during the study to take pressure off the ulcer.
They have certain other diseases, or are using certain types of drugs.

Arm && Interventions

Group	Intervention	Description
1	MRE0094	-
2	Vehicle gel	-

Primary Outcome Measures

Name	Time	Method
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.	Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).	Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.	From baseline to the various treatment visits
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.	Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)

Secondary Outcome Measures

Name	Time	Method
Incidence of complete healing of target ulcer	At endpoint or 90 days, whichever is earlier
Time to closure and percent reduction in surface area of the target ulcer.	From baseline (Day 1) to the various treatment visits

Locations (19): Associated Foot & Ankle Specialists, LLC
🇺🇸
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸
Tucson, Arizona, United States
Roy O. Kroeker, DPM
🇺🇸
Fresno, California, United States
Innovative Medical Technologies
🇺🇸
Los Angeles, California, United States
Diabetic Foot & Wound Center
🇺🇸
Denver, Colorado, United States
North American Center for Limb Preservation
🇺🇸
New Haven, Connecticut, United States
Karr Foot & Leg Centers
🇺🇸
Lakeland, Florida, United States
University of Miami
🇺🇸
Miami, Florida, United States
Ankle and Foot Specialist of Atlanta
🇺🇸
Lithonia, Georgia, United States
Foot Healthcare Associates
🇺🇸
Livonia, Michigan, United States
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Associated Foot & Ankle Specialists, LLC
🇺🇸Phoenix, Arizona, United States