NCT00318214

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Foot Ulcer, Diabetic
• Diabetes Complications

Interventions

Type	Name	Description
DRUG	MRE0094	Gel, 500 mcg/g once each day
DRUG	Vehicle gel	Gel administered once per day

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-04-26
• Last updated: 2012-06-01

Locations

19 sites across 1 country: United States