- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567397
Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Markgröningen, Germany
- Prof. Dr. Max Haerle
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Munich, Germany
- Prof. Dr. Riccardo Giunta
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Various cities, Germany
- Several undisclosed sites
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Vogtareuth, Germany
- Dr. Joerg Witthaut
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Pittrow, MD, PhD, Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
- Principal Investigator: Wilhelm Kirch, MD, PhD, Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany
- Study Director: Max Härle, MD, Orthopädische Klinik, Markgröningen, Germany
- Study Director: Jörg Witthaut, MD, Schon Klinik Vogtareuth
- Study Director: Riccardo Giunta, MD, Hand Surgery, Ludwig-Maximilian-University Munich, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ReDuCTO ID 7090
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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