Status:
TERMINATED
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, 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. The purpose of the study is to determine the safety of the experiment...
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 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00318214
Start Date
June 1 2006
End Date
February 1 2008
Last Update
June 1 2012
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
2
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
3
Roy O. Kroeker, DPM
Fresno, California, United States, 93710
4
Innovative Medical Technologies
Los Angeles, California, United States, 90063