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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
  Purpose
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.

Condition
Dupuytren's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX

Resource links provided by NLM:


Further study details as provided by Robert Hotchkiss, Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: 30 day follow up ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving treatment with XIAFLEX for Dupuytren's Disease
Criteria

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
  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): NCT01446432


Locations
United States, New York
Hospital For Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Robert Hotchkiss
Auxilium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Robert N Hotchkiss, MD Hosptial for Special Surgery
  More Information

Responsible Party: Robert Hotchkiss, MD, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01446432     History of Changes
Other Study ID Numbers: 11011
First Submitted: October 3, 2011
First Posted: October 5, 2011
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Robert Hotchkiss, Hospital for Special Surgery, New York:
Dupuytren's Contracture

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


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