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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
  Purpose

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.


Condition Intervention Phase
Dupuytren's Contracture
 Biological: clostridial collagenase injectable
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Resource links provided by NLM:

Drug Information available for: Collagenase
U.S. FDA Resources

Further study details as provided by Indiana Hand to Shoulder Center:

Primary Outcome Measures:
  • Reduction in the primary contracture to 0-5 degrees [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Clinical Improvement (>50% reduction in contracture) [ Time Frame: 30 days after last injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active treatment
Patients with thumb contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
 Biological: clostridial collagenase injectable
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Other Name: Xiaflex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265420

Locations
United States, Indiana
Indiana Hand to Shoulder Center Recruiting
Indianaplis, Indiana, United States, 46260
Contact: Suzanne Cornelius, PA-C     317-875-9105        
Contact: F. Thomas D. Kaplan, MD     317-875-9105        
Principal Investigator: F. Thomas D. Kaplan, MD            
Sub-Investigator: Gregory A Merrell, MD            
Sponsors and Collaborators
Indiana Hand to Shoulder Center
  More Information

Publications:

Responsible Party: F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier: NCT01265420     History of Changes
Other Study ID Numbers: IHtSC-Thumb 101
Study First Received: December 21, 2010
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Hand to Shoulder Center:
Dupuytren
Dupuytren's Disease

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
 Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 18, 2013