Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
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:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 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 802-247-09-029 Trial.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer|
- Primary Objective [ Time Frame: 12 months ]The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.
- Exploratory Objectives [ Time Frame: 12 Months ]The Health Economic objective for this study is 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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658618
Show 49 Study Locations
|Study Chair:||Herbert B Slade, MD||Chief Medical Officer|
|Study Director:||Tommy Lee, MSHS||Associate Director Clinical Operations|
|Principal Investigator:||Robert Kirsner, MD||Investigator|
|Principal Investigator:||William Marston, MD||Investigator|