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Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

Venous Leg Ulcer Clinical Trial

Official title:
A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

Clinical Trial Summary

This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). 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 802-247-09-029 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 802-247-09-029 Trial.

Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01658618
Study type Observational
Source Healthpoint
Contact
Status Unknown status
Phase N/A
Start date September 2012
Completion date May 2015
View Details
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