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Validation of Two New Questionnaires for Dupuytren's Disease

This study is currently recruiting participants.
Verified March 2013 by Hospital for Special Surgery, New York
Sponsor:
Collaborator:
Auxilium Pharmaceuticals, Inc
Information provided by (Responsible Party):
Robert Hotchkiss, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01446432
First received: October 3, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

October 3, 2011
March 18, 2013
February 2011
December 2013   (final data collection date for primary outcome measure)
QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: 30 day follow up ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01446432 on ClinicalTrials.gov Archive Site
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Validation of Two New Questionnaires for Dupuytren's Disease
A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX

A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients receiving treatment with XIAFLEX for Dupuytren's Disease
Dupuytren's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has a diagnosis of Dupuytren's Disease in at least one finger
  • Patients will be 35 years of age or older
  • Patients will be able to read, speak, and understand English
  • Patients will be able to provide voluntary written consent to participate

Exclusion Criteria:

  • Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
  • Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
  • Patient has a known allergy to collagenase or any other excipient of XIAFLEX.
  • Patient has received any collagenase treatments before the first dose of XIAFLEX.
  • Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study
Both
35 Years and older
No
Contact: Quynh Tran 212-774-2981 TranQ@hss.edu
United States
 
NCT01446432
11011
No
Robert Hotchkiss, Hospital for Special Surgery, New York
Robert Hotchkiss
Auxilium Pharmaceuticals, Inc
Principal Investigator: Robert N Hotchkiss, MD Hosptial for Special Surgery
Hospital for Special Surgery, New York
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP