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).
Study Type
OBSERVATIONAL
Enrollment
440
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Primary Objective
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.
Time frame: 12 months
Exploratory Objectives
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.
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carlsbad, California, United States
Unnamed facility
Castro Valley, California, United States
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Laguna Hills, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
...and 39 more locations