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MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Sponsored by Hospital for Special Surgery, New York

About this trial

Last updated 8 years ago

Study ID

11052

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
35+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 13 years ago

What is this trial about?

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

What are the participation requirements?

Yes

Inclusion Criteria

- Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.

- Subject has only one finger affected by the disease.

- Patients will be 35 years of age of older.

- Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

No

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 known allergy to collagenase or any other excipient of Xiaflex.

- Patient has received any collagenase treatments before the first dose of Xiaflex.

- Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.