Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

This study is currently recruiting participants.

Verified September 2012 by Indiana Hand to Shoulder Center

Sponsor:

Information provided by (Responsible Party):

F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center

ClinicalTrials.gov Identifier:

NCT01265420

First received: December 21, 2010

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 21, 2010
Last Updated Date	September 11, 2012
Start Date ^ICMJE	December 2010
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 22, 2010)	Reduction in the primary contracture to 0-5 degrees [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01265420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 22, 2010)	Percentage of Clinical Improvement (>50% reduction in contracture) [ Time Frame: 30 days after last injection ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Official Title ^ICMJE	The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Dupuytren's Contracture
Intervention ^ICMJE	Biological: clostridial collagenase injectable Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections Other Name: Xiaflex
Study Arm (s)	Experimental: active treatment Patients with thumb contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase Intervention: Biological: clostridial collagenase injectable
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	July 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01265420
Other Study ID Numbers ^ICMJE	IHtSC-Thumb 101
Has Data Monitoring Committee	No
Responsible Party	F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center
Study Sponsor ^ICMJE	Indiana Hand to Shoulder Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Indiana Hand to Shoulder Center
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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