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

• HP802-247 (Biological)

Primary outcomes

• Primary Objective [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.

Secondary outcomes

• Exploratory Objectives [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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Provide informed consent document
* Subject was randomized in 802-247-09-029 and received at least one application of a test article.
* Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.

Exclusion Criteria:

* Subjects who refuse to provide written informed consent will be excluded from this trial.

• Herbert B Slade, MD, Study chair, Chief Medical Officer
• Tommy Lee, MSHS, Study director, Associate Director Clinical Operations
• Robert Kirsner, MD, Principal investigator, Investigator
• William Marston, MD, Principal investigator, Investigator