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

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.
 
ClinicalTrials.gov Identifier: NCT01226121
Recruitment Status : Terminated (difficulty enrolling additional patients)
First Posted : October 21, 2010
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dupuytren's Disease Biological: Clostridial collagenase injectable Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) [ Time Frame: 30 days after injection ]

Secondary Outcome Measures :
  1. Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01226121


Locations
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United States, Indiana
Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States, 46260
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Indiana Hand to Shoulder Center
Stony Brook University
Investigators
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Principal Investigator: F. Thomas D. Kaplan, MD Indiana Hand to Shoulder Center
Principal Investigator: Lawrence C Hurst, MD Stony Brook University
More Information
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Publications:

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Responsible Party: F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier: NCT01226121    
Other Study ID Numbers: IHtSC-Delay 101
First Posted: October 21, 2010    Key Record Dates
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014
Last Verified: May 2014
Keywords provided by F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center:
dupuytren
dupuytren's
Additional relevant MeSH terms:
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Dupuytren Contracture
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