You are here

Our science / Clinical Trials / Find a Trial / NCT00765063

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

Back to Search Print Save as PDF Bookmark Trial

NCT00765063

Last updated on May 10, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wien, , A-1090 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

- 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)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Ulcerative Colitis
Xeljanz Special Investigation for Long-term Use in UC Patients
NCT03643211
All Genders
20+
Years
Tokyo,
Ulcerative Colitis
PF-06687234 add on therapy in active UC subjects - BUILD UC
NCT03269695
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
NCT03281304
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865
All Genders
18+
Years
Multiple Sites
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

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now