Venous Leg Ulcer (VLU) Clinical Trial
Official title:
An Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)
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:
1. to identify new adverse events,
2. to examine ongoing adverse events not resolved in subjects who participated in the
802-247-09-032 trial,
3. to record wound status, and
4. 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.
Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02167815 -
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
|
N/A |