Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)

This study has been completed.
Sponsor:
Collaborators:
GWT-TUD GmbH
Pfizer
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01567397
First received: March 28, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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
Dupuytren's Disease

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

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Dupuytren's Disease

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567397

Locations
Germany
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
GWT-TUD GmbH
Pfizer
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 Schön Klinik Vogtareuth
Study Director: Riccardo Giunta, MD Hand Surgery, Ludwig-Maximilian-University Munich, Germany
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01567397     History of Changes
Other Study ID Numbers: ReDuCTO ID 7090
Study First Received: March 28, 2012
Last Updated: November 7, 2013
Health Authority: Germany: Ethikkommission an der TU Dresden

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014