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

Completed

• Conditions: Venous Leg Ulcer (VLU)

• Registration Number: NCT01970657
• Lead Sponsor: Healthpoint

Brief Summary

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). 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 802-247-09-032 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 802-247-09-032 Trial.

About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Study Start: 2014-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.