Status:
COMPLETED
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
Lead Sponsor:
Pfizer
Conditions:
Foot Ulcer, Diabetic
Diabetes Complications
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 (MRE0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00312364
Start Date
December 1 2005
End Date
December 1 2007
Last Update
June 1 2012
Active Locations (63)
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1
Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
2
Palo Verde Foot and Ankle
Bullhead City, Arizona, United States, 86442
3
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
4
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015