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Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

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NCT00662831

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Klagenfurt, , A-9020 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Foot Ulcer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects 18 years of age with type 1 or type 2 diabetes.

- Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability
score (NDS) of >3

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

- Subjects who have undergone vascular reconstruction or angioplasty less than 1 month
prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B
or D according to the University of Texas wound classification system.

- Subjects with a known bleeding disorder or evidence of active bleeding.

NCT00662831
Pfizer
Completed
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

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Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ?50% reduction in ulcer surface area including intact skin healing.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • Drug: Fragmin/ Dalteparin Sodium
    Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
  • Drug: Placebo for Fragmin/ Dalteparin Sodium
    Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
  • Experimental: Active
    Active study treatment
    Intervention: Drug: Fragmin/ Dalteparin Sodium
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo for Fragmin/ Dalteparin Sodium
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects 18 years of age with type 1 or type 2 diabetes.
  • Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of >3

Exclusion Criteria:

  • Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
  • Subjects with a known bleeding disorder or evidence of active bleeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
France,   Netherlands
 
NCT00662831
A6301083
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

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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1-800-718-1021

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