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

• Conditions: Venous Leg Ulcer

• Registration Number: NCT01658618
• Lead Sponsor: Healthpoint

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-07
• Study Start: 2012-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03
• Primary Completion: 2015-03
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.