Diabetes Complications, Foot Ulcer, Diabetic
Conditions
Keywords
toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes
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.
Interventions
DRUGMRE0094
Gel, 500 mcg/g once each day
DRUGVehicle gel
Gel administered once per day
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed