NCT01567397

Registry of Dupuytren's Contracture Treatment Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 87 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dupuytren's Disease

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-03-30
• Last updated: 2016-12-22

Locations

4 sites across 1 country: Germany