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Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). This study is being done for the following purposes:
to identify new adverse events,
to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
to record wound status, and
to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-032 Trial.
About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.