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Completed

NCT Number: NCT01450397

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

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

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hosptial for Special Surgery

New York, 10021, United States

About this study

Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

XIAFLEX

Biological

One Injection of 0.58 mg of Xiaflex into the affected area of the hand.

Other names: Collagenase

Primary outcomes

  1. The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.

    Time frame: Baseline and 30 days

    Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Auxilium Pharmaceuticals, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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