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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wien, , A-1090 Austria
Contact
1-800-718-1021
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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The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
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
The 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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetic Foot Ulcer
Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Other Name: Dalteparin sodium
Experimental: Active
Active study treatment
Intervention: Drug: Fragmin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
October 2010
October 2010   (Final data collection date for primary outcome measure)

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
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,   Germany,   Greece,   Italy,   Norway,   Poland,   Russian Federation,   Sweden,   Ukraine,   United Kingdom
Lithuania,   Spain
 
NCT00765063
A6301086
No
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

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1-800-718-1021

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