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

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: NCT01265420
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : April 9, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center

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.

Condition or disease Intervention/treatment Phase
Dupuytren's Contracture Biological: Injectable clostridial collagenase Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
Study Start Date : December 2010
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Injectable clostridial collagenase
Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
Biological: Injectable clostridial collagenase
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Other Name: Xiaflex



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01265420


Locations
United States, Indiana
Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States, 46260
Sponsors and Collaborators
Indiana Hand to Shoulder Center

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
First Posted: December 23, 2010    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center:
Dupuytren
Dupuytren's Disease

Additional relevant MeSH terms:
Contracture
Dupuytren 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