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

March 20, 2017 updated by: Hospital for Special Surgery, New York
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hosptial for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: XIAFLEX
XIAFlEX
Biological: XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Names:
  • Collagenase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Auxilium Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Scott W Wolfe, MD, Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11052 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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