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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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 with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight

Criteria

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