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

Study Overview
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Brief Summary
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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.

Conditions
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Foot Ulcer, Diabetic, Diabetes Complications

Intervention / Treatment
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* Drug: MRE0094
* Drug: Vehicle gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRE0094<br>* Gel, 500 mcg/g once each day<br>|
| Placebo Comparator: 2<br> | Drug: Vehicle gel<br>* Gel administered once per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes