Overview

This trial is active, not recruiting.

Condition dupuytren's disease
Sponsor Robert Hotchkiss
Collaborator Auxilium Pharmaceuticals, Inc
Start date February 2011
End date December 2015
Trial size 80 participants
Trial identifier NCT01446432, 11011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
QuickDASH (Disability of the Arm, Shoulder, and Hand)
time frame: 30 day follow up

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
Principal investigator Robert N Hotchkiss, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Hospital for Special Surgery, New York.