NCT01450397已完成4 期
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
研究概览
简要总结
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
详细描述
Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
- •Subject has only one finger affected by the disease.
- •Patients will be 35 years of age of older.
- •Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.
排除标准
- •Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
- •Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
- •Patient has known allergy to collagenase or any other excipient of Xiaflex.
- •Patient has received any collagenase treatments before the first dose of Xiaflex.
- •Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
结局指标
主要结局
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
时间窗: Baseline and 30 days
Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.
次要结局
未报告次要终点
研究者
研究点 (1)
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