NCT01658618Unknown不适用
A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Healthpoint
- 入组人数
- 440
- 主要终点
- Primary Objective
研究概览
简要总结
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:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
- to record wound status, and
- 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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects who refuse to provide written informed consent will be excluded from this trial.
结局指标
主要结局
Primary Objective
时间窗: 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.
次要结局
- Exploratory Objectives(12 Months)
研究者
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