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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Page 1 of 16 (63 locations)

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