Status:
COMPLETED
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
Lead Sponsor:
Pfizer
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00765063
Start Date
October 1 2008
End Date
October 1 2010
Last Update
January 13 2012
Active Locations (27)
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1
Pfizer Investigational Site
Vienna, Austria, A-1090
2
Pfizer Investigational Site
Ransart, Belgium, 6043
3
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
4
Pfizer Investigational Site
Prague, Czechia, 150 06