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

Dupuytren's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450397
• Other study ID #: 11052
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2011
• Last updated: May 19, 2014
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Biological:
• XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.

Locations

Country	Name	City	State
United States	Hosptial for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Scott Wolfe	Auxilium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.	Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.	Baseline and 30 days	No