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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Foot Ulcer, Diabetic

Diabetes Complications

Treatments

Drug: MRE0094

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312364

MRE0094P-201

Details and patient eligibility

About

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.

Enrollment

322 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.