- 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
- 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