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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
  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

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

Primary Outcome Measures:
  • QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: 30 day follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446432

Contacts
Contact: Quynh Tran 212-774-2981 TranQ@hss.edu

Locations
United States, New York
Hospital For Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Quynh Tran     212-774-2981     TranQ@hss.edu    
Sponsors and Collaborators
Robert Hotchkiss
Auxilium Pharmaceuticals, Inc
Investigators
Principal Investigator: Robert N Hotchkiss, MD Hosptial for Special Surgery
  More Information

No publications provided

Responsible Party: Robert Hotchkiss, MD, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01446432     History of Changes
Other Study ID Numbers: 11011
Study First Received: October 3, 2011
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013