Validation of Two New Questionnaires for Dupuytren's Disease

NCT ID: NCT01446432

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dupuytren's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Auxilium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Robert Hotchkiss

OTHER

Sponsor Role lead

Responsible Party

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Robert Hotchkiss

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert N Hotchkiss, MD

Role: PRINCIPAL_INVESTIGATOR

Hosptial for Special Surgery

Locations

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Hospital For Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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11011

Identifier Type: -

Identifier Source: org_study_id

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