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临床试验/NCT01567397
NCT01567397已完成不适用

Registry of Dupuytren's Contracture Treatment Outcomes

Technische Universität Dresden4 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
4

研究概览

简要总结

Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the

  • Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
  • Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
  • Effectiveness (with focus on functionality)
  • Tolerability
  • Patient-related outcomes: patient satisfaction, health-related quality of life
  • Physician satisfaction with therapy
  • Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
  • Long-term outcomes

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • palpable cord due to Dupuytren's Disease (pretreated or untreated)
  • satisfactory knowledge of German to be able to fill out questionnaires
  • written informed consent

排除标准

  • contraindication to Microbial Collagenase (according to Prescription Information)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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