Validation of Two New Questionnaires for Dupuytren's Disease
Verified February 2014 by Hospital for Special Surgery, New York
Auxilium Pharmaceuticals, Inc
Information provided by (Responsible Party):
Robert Hotchkiss, Hospital for Special Surgery, New York
First received: October 3, 2011
Last updated: February 26, 2014
Last verified: February 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
Primary Outcome Measures:
- QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: 30 day follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||35 Years and older
|Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446432
|Hospital For Special Surgery
|New York, New York, United States, 10021 |
|Contact: Quynh Tran 212-774-2981 TranQ@hss.edu |
Auxilium Pharmaceuticals, Inc
||Robert N Hotchkiss, MD
||Hosptial for Special Surgery
No publications provided
||Robert Hotchkiss, MD, Hospital for Special Surgery, New York
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 3, 2011
||February 26, 2014
||United States: Institutional Review Board
Keywords provided by Hospital for Special Surgery, New York:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
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