Validation of Two New Questionnaires for Dupuytren's Disease
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ClinicalTrials.gov Identifier: NCT01446432
Verified April 2015 by Robert Hotchkiss, Hospital for Special Surgery, New York. Recruitment status was: Active, not recruiting
: October 5, 2011
Last Update Posted
: April 3, 2015
Auxilium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Robert Hotchkiss, Hospital for Special Surgery, New York
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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Ages Eligible for Study:
35 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients receiving treatment with XIAFLEX for Dupuytren's Disease
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
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