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Completed

NCT Number: NCT01265420

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

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.

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Key information

Conditions

Dupuytren's Contracture Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana Hand to Shoulder Center

Indianaplis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injectable clostridial collagenase

Biological

Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Other names: Xiaflex

Primary outcomes

  1. Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)

    Time frame: 30 days after last injection

Sponsors and collaborators

Lead sponsor

Indiana Hand to Shoulder Center

Other

Registry information

Official study title

The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2010
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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