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

NCT01450397 — Phase 4, Completed, 5 participants, Hospital for Special Surgery, New York

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RegistryNCT01450397
StatusCompleted
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment5 (Actual)
SponsorHospital for Special Surgery, New York (Other); collaborators: Auxilium Pharmaceuticals, Inc.
ConditionsDupuytren's Disease
InterventionsXIAFLEX (Biological)
Datesstart 2011-03-01, primary completion 2012-01-01, completion 2012-02-01, first posted 2011-10-12, last updated 2017-04-17
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Dupuytren's Disease All trials of XIAFLEX

-Summary

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

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
XIAFLEXOtherBiological: XIAFLEXXIAFlEX
  • XIAFLEX (Biological), also known as Collagenase: One Injection of 0.58 mg of Xiaflex into the affected area of the hand.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 35 Years to any

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.

+Posted results

Participant flow

MilestoneXIAFLEX
Started5
Completed5
Not completed0

Outcome results

  • The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. (Primary), Mean, mm^3: XIAFLEX 482 (188 to 670) (p <0.0013)

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
XIAFLEX00/5 (0.0%)0/5 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Hosptial for Special SurgeryNew York, New YorkUnited States

+Investigators