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The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

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NCT00765063

Last updated on November 16, 2019
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Study Location
Pfizer Investigational Site
Wien, , A-1090 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

- Subjects must have completed the 6 month study duration in the A6301083 study.

- Subjects must have a positive ulcer treatment response, defined as a reduction in the
study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from
baseline in the A6301083 study.

- All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University
of Texas wound classification system

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

- Subjects who have the following:

- Intact skin healing (defined as 100% reduction in ulcer surface area with full
epithelialisation at or prior to the EOT visit in the A6301083 study).

- A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline
ulcer area (ie, ulcer area increase ?0%) in the A6301083 study.

- Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the
University of Texas wound classification system.

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

- Subjects who are on dialysis.

- Subjects who where found to be major protocol violators in A6301083 study.

- Subjects who did not complete the 6 month study period of the A6301083 study

NCT00765063
Pfizer
Completed
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

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Descriptive Information
Brief Title  ICMJE The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
Official Title  ICMJE A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease
Brief SummaryThe primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Other Name: Dalteparin sodium
Study Arms  ICMJE Experimental: Active
Active study treatment
Intervention: Drug: Fragmin
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: March 24, 2011)		62
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)		215
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have completed the 6 month study duration in the A6301083 study.
  • Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.
  • All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system

Exclusion Criteria:

  • Subjects who have the following:
  • Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).
  • A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ?0%) in the A6301083 study.
  • Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.
  • Subjects with a known bleeding disorder or evidence of active bleeding.
  • Subjects who are on dialysis.
  • Subjects who where found to be major protocol violators in A6301083 study.
  • Subjects who did not complete the 6 month study period of the A6301083 study
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,   Czech Republic,   Denmark,   Germany,   Greece,   Italy,   Norway,   Poland,   Russian Federation,   Sweden,   Ukraine,   United Kingdom
Removed Location CountriesLithuania,   Spain
 
Administrative Information
NCT Number  ICMJE NCT00765063
Other Study ID Numbers  ICMJE A6301086
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2011

ICMJE     Data element required by the

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

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