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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 April 7, 2020
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Study Location
Pfizer Investigational Site
Klagenfurt, , A-9020 Austria
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Active
    Active study treatment
    Intervention: Drug: Fragmin/ Dalteparin Sodium
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo for Fragmin/ Dalteparin Sodium
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 5, 2011) 		276
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008) 		645
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Austria,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
Removed Location Countries Czech Republic,   France,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00662831
Other Study ID Numbers  ICMJE A6301083
Has Data Monitoring Committee Yes
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: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the

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

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