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

Last updated on March 14, 2019

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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.
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- 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.
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- 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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