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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450397
First Posted: October 12, 2011
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Auxilium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  Purpose
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

Condition Intervention Phase
Dupuytren's Disease Biological: XIAFLEX Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
XIAFLEX
XIAFlEX
Biological: XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Name: Collagenase

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450397


Locations
United States, New York
Hosptial for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Auxilium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Scott W Wolfe, MD Hospital for Special Surgery, New York
  More Information

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01450397     History of Changes
Other Study ID Numbers: 11052
First Submitted: October 10, 2011
First Posted: October 12, 2011
Results First Submitted: October 29, 2013
Results First Posted: May 15, 2014
Last Update Posted: April 17, 2017
Last Verified: March 2017

Keywords provided by Hospital for Special Surgery, New York:
Dupuytren's Contracture

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases