ClinicalTrials.gov
History of Changes for Study: NCT01567397
Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)
Latest version (submitted December 20, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 29, 2012 None (earliest Version on record)
2 July 27, 2012 Recruitment Status, Contacts/Locations, Study Status and Study Design
3 April 29, 2013 Recruitment Status, Study Status and Study Design
4 November 7, 2013 Study Status
5 December 20, 2016 Study Status, References and Eligibility
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Study NCT01567397
Submitted Date:  March 29, 2012 (v1)
Open or close this module Study Identification
Unique Protocol ID: ReDuCTO ID 7090
Brief Title: Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)
Official Title: Registry of Dupuytren's Contracture Treatment Outcomes
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2012
Overall Status: Recruiting
Study Start: December 2011
Primary Completion: June 2013 [Anticipated]
Study Completion: June 2013 [Anticipated]
First Submitted: March 28, 2012
First Submitted that
Met QC Criteria:		 March 29, 2012
First Posted: March 30, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:		 March 29, 2012
Last Update Posted: March 30, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Technische Universität Dresden
Responsible Party: Sponsor
Collaborators: GWT-TUD GmbH
Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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
Detailed Description:
Open or close this module Conditions
Conditions: Dupuytren's Disease
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 250 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: Patients with Dupuytren's Disease
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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)
Open or close this module Contacts/Locations
Central Contact Person: David Pittrow, MD, PhD
Telephone: +49351458 Ext. 2815
Email: david.pittrow@mailbox.tu-dresden.de
Central Contact Backup: Wilhelm Kirch, MD, PhD
Telephone: +49351458 Ext. 2815
Email: wilhelm.kirch@mailbox.tu-dresden.de
Study Officials: David Pittrow, MD, PhD
Study Director
Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Wilhelm Kirch, MD, PhD
Principal Investigator
Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany
Locations: Germany
Prof. Dr. Max Haerle
[Recruiting]
Markgröningen, Germany
Contact:Contact: Max Haerle, MD, PhD v.ackermann@okm.de
Prof. Dr. Riccardo Giunta
[Recruiting]
Munich, Germany
Contact:Contact: Riccardo Giunta, MD, PhD r.giunta@med.uni-muenchen.de
Several undisclosed sites
[Recruiting]
Various cities, Germany
Contact:Contact: David Pittrow, MD, PhD david.pittrow@mailbox.tu-dresden.de
Dr. Joerg Witthaut
[Recruiting]
Vogtareuth, Germany
Contact:Contact: Joerg Witthaut, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services