Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

NCT00318214

Last updated date
Study Location
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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 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 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 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.

NEED INFO?

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Pfizer Clinical Trials Contact Center

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[email protected]

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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetic Foot Ulcer, Diabetes ComplicationsSafety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
NCT00318214
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Fresno, California
  4. Los Angeles, California
  5. Denver, Colorado
  6. New Haven, Connecticut
  7. Lakeland, Florida
  8. Miami, Florida
  9. Lithonia, Georgia
  10. Livonia, Michigan
  11. Petoskey, Michigan
  12. Bronx, New York
  13. Port Jefferson Station, New York
  14. Durham, North Carolina
  15. Greenville, North Carolina
  16. Allentown, Pennsylvania
  17. Dallas, Texas
  18. Lubbock, Texas
  19. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
Official Title  ICMJE Not Provided
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 experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors.

Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Foot Ulcer, Diabetic
  • Diabetes Complications
Intervention  ICMJE
  • Drug: MRE0094
    Gel, 500 mcg/g once each day
  • Drug: Vehicle gel
    Gel administered once per day
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: MRE0094
  • Placebo Comparator: 2
    Intervention: Drug: Vehicle gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 3, 2008)
16
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318214
Other Study ID Numbers  ICMJE MRE0094P-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Robert L. Rolleri, Pharm.D.King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP