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Registry of Dupuytren's Contracture Treatment Outcomes

NCT01567397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2016-12-22

No results posted yet for this study

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

Sponsors & Collaborators

  • GWT-TUD GmbH

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • David Pittrow, MD, PhD · Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany

  • Wilhelm Kirch, MD, PhD · Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany

  • Max Härle, MD · Orthopädische Klinik, Markgröningen, Germany

  • Jörg Witthaut, MD · Schön Klinik Vogtareuth

  • Riccardo Giunta, MD · Hand Surgery, Ludwig-Maximilian-University Munich, Germany

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567397 on ClinicalTrials.gov