Back to resultsEfficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Primary Purpose
Dupuytren's Contracture
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Injectable clostridial collagenase
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren's Contracture focused on measuring Dupuytren, Dupuytren's Disease
Eligibility Criteria
Inclusion Criteria:
- Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb
- First web space contracture with a palpable cord due to Dupuytren's contracture
Exclusion Criteria:
- Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
- 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).
- Pregnant or nursing female
- Any subject who cannot conform to the study visit schedule
Sites / Locations
- Indiana Hand to Shoulder Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injectable clostridial collagenase
Arm Description
Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
Outcomes
Primary Outcome Measures
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
Secondary Outcome Measures
Full Information
NCT ID
NCT01265420
First Posted
December 21, 2010
Last Updated
April 8, 2015
Sponsor
Indiana Hand to Shoulder Center
1. Study Identification
Unique Protocol Identification Number
NCT01265420
Brief Title
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Official Title
The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana Hand to Shoulder Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Contracture
Keywords
Dupuytren, Dupuytren's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injectable clostridial collagenase
Arm Type
Experimental
Arm Description
Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
Intervention Type
Biological
Intervention Name(s)
Injectable clostridial collagenase
Other Intervention Name(s)
Xiaflex
Intervention Description
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Primary Outcome Measure Information:
Title
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
Time Frame
30 days after last injection
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 MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb
First web space contracture with a palpable cord due to Dupuytren's contracture
Exclusion Criteria:
Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
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).
Pregnant or nursing female
Any subject who cannot conform to the study visit schedule
Facility Information:
Facility Name
Indiana Hand to Shoulder Center
City
Indianaplis
State/Province
Indiana
ZIP/Postal Code
46260
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
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Learn more about this trial
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
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