Validation of Two New Questionnaires for Dupuytren's Disease

Dupuytren's Disease Clinical Trial

Official title:

A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01446432
• Other study ID #: 11011
• Status: Active, not recruiting
• Phase: N/A
• First received: October 3, 2011
• Last updated: April 1, 2015
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

Locations

Country	Name	City	State
United States	Hospital For Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Robert Hotchkiss	Auxilium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QuickDASH (Disability of the Arm, Shoulder, and Hand)		30 day follow up	No