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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00312364
First received: April 6, 2006
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Foot Ulcer, Diabetic
Diabetes Complications
Drug: MRE0094
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.

Secondary Outcome Measures:
  • Time to closure and percent reduction in surface area of the target ulcer.
  • Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.

Enrollment: 322
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312364

  Show 63 Study Locations
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312364     History of Changes
Other Study ID Numbers: MRE0094P-201
Study First Received: April 6, 2006
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
toe ulcer
heel ulcer
foot ulcer
diabetic feet
diabetic foot
complications of diabetes

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Diabetes Complications
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on October 16, 2014