Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

May 16, 2014 updated by: F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center

A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

Study Type

Interventional

Enrollment (Actual)

37

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
    • Indiana
      • Indianaplis, Indiana, United States, 46260
        • Indiana Hand to Shoulder Center
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

Exclusion Criteria:

  • Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
  • Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
  • Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
  • Any subject with known allergy to Xiaflex (Clostridial collagenase).
  • Any subject who cannot conform to the study visit schedule

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Day 1 manipulation
Finger manipulation one day following Clostridial collagenase injectable
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Active Comparator: Day 2 manipulation
Finger manipulation two days following Clostridial collagenase injectable
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Active Comparator: Day 4 manipulation
Finger manipulation four days following Clostridial collagenase injectable
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Time Frame: 30 days after injection
30 days after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Indiana Hand to Shoulder Center

Collaborators

Stony Brook University

Investigators

  • Principal Investigator: F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center
  • Principal Investigator: Lawrence C Hurst, MD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHtSC-Delay 101

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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