NCT01381770已完成2 期
Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.
研究概览
简要总结
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •age > 18 years old
- •if woman, no pregnancy ongoing
- •muscular lesion grade 2 or 3 in a lower limb muscular group
排除标准
- •no hematological conditions
- •no anticoagulation in the two preceding weeks
结局指标
主要结局
number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.
时间窗: 21 days from enrollment
If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded "successful"; and "unsuccessful" otherwise
次要结局
- time-to-healing at ultrasound(within 4 months from treatment)
- Time-to-return to sport activities(within 4 months from lesion)
- Side effects(within 4 months from treatment)
- side effects(within 4 months from treatment)
研究者
Claudio Pavesi
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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