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

NCT00312364

Last updated date
Study Location
Institute for Advanced Wound Care
Montgomery, Alabama, 36111, 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]

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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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Diabetic Foot Ulcer, Diabetes ComplicationsSafety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
NCT00312364
  1. Montgomery, Alabama
  2. Bullhead City, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Tucson, Arizona
  6. Tucson, Arizona
  7. Bakersfield, California
  8. Fresno, California
  9. Los Angeles, California
  10. San Diego, California
  11. San Francisco, California
  12. Santa Rosa, California
  13. Denver, Colorado
  14. New Haven, Connecticut
  15. Wilmington, Delaware
  16. Clearwater, Florida
  17. Lakeland, Florida
  18. Miami, Florida
  19. Pensacola, Florida
  20. South Miami, Florida
  21. Tamarac, Florida
  22. Lithonia, Georgia
  23. Boise, Idaho
  24. Highland Park, Illinois
  25. Niles, Illinois
  26. North Chicago, Illinois
  27. Peoria, Illinois
  28. Urbana, Illinois
  29. Evansville, Indiana
  30. Terre Haute, Indiana
  31. Baton Rouge, Louisiana
  32. Ann Arbor, Michigan
  33. Livonia, Michigan
  34. Petoskey, Michigan
  35. Union, New Jersey
  36. Bronx, New York
  37. Elmhurst, New York
  38. Port Jefferson Station, New York
  39. Williamsville, New York
  40. Durham, North Carolina
  41. Greenville, North Carolina
  42. Bismarck, North Dakota
  43. Austintown, Ohio
  44. Cincinnati, Ohio
  45. Cleveland, Ohio
  46. Columbus, Ohio
  47. Allentown, Pennsylvania
  48. Altoona, Pennsylvania
  49. Farrell, Pennsylvania
  50. Hershey, Pennsylvania
  51. Philadelphia, Pennsylvania
  52. Dallas, Texas
  53. Dallas, Texas
  54. Floresville, Texas
  55. Houston, Texas
  56. Lubbock, Texas
  57. San Antonio, Texas
  58. San Antonio, Texas
  59. Bountiful, Utah
  60. Salt Lake City, Utah
  61. Virginia Beach, Virginia
  62. Tacoma, Washington
  63. Milwaukee, Wisconsin
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+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of MRE0094 to Treat 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.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Foot Ulcer, Diabetic
  • Diabetes Complications
Intervention  ICMJE Drug: MRE0094
Study Arms  ICMJE Not Provided
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2008)
322
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (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 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.
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 NCT00312364
Other Study ID Numbers  ICMJE MRE0094P-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
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