Validation of Two New Questionnaires for Dupuytren's Disease

Robert Hotchkiss

Status: Unknown

Conditions: Dupuytren's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01446432

11011 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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