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. 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.
Interventions
DRUGMRE0094
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to closure and percent reduction in surface area of the target ulcer. | — |
| Incidence, intensity, and seriousness of adverse events. Changes in irritation scores. | — |
Countries
United States
Outcome results
None listed