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Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 30, 2012
Last Update Posted: December 22, 2016
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.
Information provided by (Responsible Party):
Technische Universität Dresden

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

Dupuytren's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Dupuytren's Contracture Treatment Outcomes

Resource links provided by NLM:

Further study details as provided by Technische Universität Dresden:

Enrollment: 87
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01567397

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
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
  More Information

Additional Information:
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01567397     History of Changes
Other Study ID Numbers: ReDuCTO ID 7090
First Submitted: March 28, 2012
First Posted: March 30, 2012
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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