NCT01446432Unknown不适用
A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
Robert Hotchkiss1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- QuickDASH (Disability of the Arm, Shoulder, and Hand)
研究概览
简要总结
A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.
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
- 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 in at least one finger
- •Patients will be 35 years of age or older
- •Patients will be able to read, speak, and understand English
- •Patients will 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 a known allergy to collagenase or any other excipient of XIAFLEX.
- •Patient has received any collagenase treatments before the first dose of XIAFLEX.
- •Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study
结局指标
主要结局
QuickDASH (Disability of the Arm, Shoulder, and Hand)
时间窗: 30 day follow up
次要结局
未报告次要终点
研究者
Robert Hotchkiss
MD
Hospital for Special Surgery, New York
研究点 (1)
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