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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015 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 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.

NCT00318214
Pfizer
Terminated
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

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Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, 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. 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.

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
February 2008
February 2008   (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 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.
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
 
 
NCT00318214
MRE0094P-202
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Robert L. Rolleri, Pharm.D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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