Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247

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.

• No treatment specified (Biological): No intervention
• No treatment (Biological): None specified

Primary outcomes

• Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial. [Up to 12 months from first application of test article in the 802-247-09-032 study]: The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the prior study.

Secondary outcomes

• Follow-up on the status of the target ulcer as open, re-opened or closed. [Up to 12 months from first application of test article in the 802-247-09-032 study]: At each study visit the status of the target ulcer was assessed as remaining closed, re-opened, or a new closure.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
* Subject was randomized in 802-247-09-032 and received at least one application of test article.
* Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.

Exclusion Criteria:

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

• Wolfgang Vanscheidt, MD, Principal investigator, University Freiburg-Practice for Dermatology