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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Institute for Advanced Wound Care
Montgomery, Alabama, 36111 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Foot Ulcer, Diabetes Complications
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00312364
Pfizer
Completed
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

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[email protected]

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Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Foot Ulcer, Diabetic
  • Diabetes Complications
Drug: MRE0094
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
December 2007
December 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00312364
MRE0094P-201
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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