Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Primary Purpose
Dupuytren's Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clostridial collagenase injectable
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren's Disease focused on measuring dupuytren, dupuytren's
Eligibility 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
Sites / Locations
- Indiana Hand to Shoulder Center
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Day 1 manipulation
Day 2 manipulation
Day 4 manipulation
Arm Description
Finger manipulation one day following Clostridial collagenase injectable
Finger manipulation two days following Clostridial collagenase injectable
Finger manipulation four days following Clostridial collagenase injectable
Outcomes
Primary Outcome Measures
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Secondary Outcome Measures
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Full Information
NCT ID
NCT01226121
First Posted
October 20, 2010
Last Updated
May 16, 2014
Sponsor
Indiana Hand to Shoulder Center
Collaborators
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT01226121
Brief Title
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
difficulty enrolling additional patients
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana Hand to Shoulder Center
Collaborators
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Disease
Keywords
dupuytren, dupuytren's
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day 1 manipulation
Arm Type
Active Comparator
Arm Description
Finger manipulation one day following Clostridial collagenase injectable
Arm Title
Day 2 manipulation
Arm Type
Active Comparator
Arm Description
Finger manipulation two days following Clostridial collagenase injectable
Arm Title
Day 4 manipulation
Arm Type
Active Comparator
Arm Description
Finger manipulation four days following Clostridial collagenase injectable
Intervention Type
Biological
Intervention Name(s)
Clostridial collagenase injectable
Intervention Description
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Primary Outcome Measure Information:
Title
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Time Frame
30 days after injection
Secondary Outcome Measure Information:
Title
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Thomas D. Kaplan, MD
Organizational Affiliation
Indiana Hand to Shoulder Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence C Hurst, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Hand to Shoulder Center
City
Indianaplis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19726771
Citation
Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
Results Reference
background
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Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
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