Skip to content

Validation of Two New Questionnaires for Dupuytren's Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01446432
Enrollment
80
Registered
2011-10-05
Start date
2011-02-28
Completion date
2015-12-31
Last updated
2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's Disease

Keywords

Dupuytren's Contracture

Brief 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.

Interventions

None listed

Sponsors

Auxilium Pharmaceuticals, Inc.
CollaboratorINDUSTRY
Robert Hotchkiss
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026