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Validation of Two New Questionnaires for Dupuytren's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Robert Hotchkiss, Hospital for Special Surgery, New York.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446432
First Posted: October 5, 2011
Last Update Posted: April 3, 2015
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.
Collaborator:
Auxilium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Robert Hotchkiss, Hospital for Special Surgery, New York
October 3, 2011
October 5, 2011
April 3, 2015
February 2011
December 2015   (Final data collection date for primary outcome measure)
QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: 30 day follow up ]
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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.
Not Provided
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.
 
Unknown status
80
December 2015
December 2015   (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
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01446432
11011
No
Not Provided
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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
April 2015