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Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567397
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Technische Universität Dresden

Brief 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

Condition or disease
Dupuytren's Disease

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Dupuytren's Contracture Treatment Outcomes
Study Start Date : December 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Dupuytren's Disease

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567397

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Prof. Dr. Max Haerle
Markgröningen, Germany
Prof. Dr. Riccardo Giunta
Munich, Germany
Several undisclosed sites
Various cities, Germany
Dr. Joerg Witthaut
Vogtareuth, Germany
Sponsors and Collaborators
Technische Universität Dresden
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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 Schön Klinik Vogtareuth
Study Director: Riccardo Giunta, MD Hand Surgery, Ludwig-Maximilian-University Munich, Germany

Additional Information:
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Responsible Party: Technische Universität Dresden Identifier: NCT01567397     History of Changes
Other Study ID Numbers: ReDuCTO ID 7090
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Connective Tissue Diseases