A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 206
- 试验地点
- 30
- 主要终点
- The Number of Participants With Closed Target Ulcers at Each Visit
研究概览
简要总结
This is a 24-week observational follow safety study for Study 802-247-09-015.
详细描述
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Number of Participants With Closed Target Ulcers at Each Visit
时间窗: Over the 24-week study period, at each of the bi-monthly visits
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
时间窗: Over the 24-week study period, at each of the bi-monthly visits
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
次要结局
未报告次要终点