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OpenTrials
Completed

NCT Number: NCT01567397

Registry of Dupuytren's Contracture Treatment Outcomes

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Max Haerle, Markgröningen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • contraindication to Microbial Collagenase (according to Prescription Information)

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • GWT-TUD GmbH
  • Pfizer

Registry information

Acronym: ReDuCTO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 30, 2012
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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