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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312364
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : June 1, 2012
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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 (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 or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Diabetes Complications Drug: MRE0094 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312364

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Sponsors and Collaborators
Layout table for additonal information Identifier: NCT00312364    
Other Study ID Numbers: MRE0094P-201
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Pfizer:
toe ulcer
heel ulcer
foot ulcer
diabetic feet
diabetic foot
complications of diabetes
Additional relevant MeSH terms:
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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