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Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01538017
First received: February 18, 2012
Last updated: October 3, 2016
Last verified: October 2016
February 18, 2012
October 3, 2016
February 2012
October 2016   (Final data collection date for primary outcome measure)
Clinical improvement [ Time Frame: 2 years ]
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
Same as current
Complete list of historical versions of study NCT01538017 on ClinicalTrials.gov Archive Site
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Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dupuytrens Contracture
  • Drug: Xiapex
    Collagenase Clostridium Histolyticum
    Other Name: XIAPEX® - Pfizer UK
  • Procedure: Percutaneous needle fasciotomy
    Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
  • Active Comparator: Collagenase injection
    Injection of collagenase obtained from Clostridium Histolyticum in contracture string
    Intervention: Drug: Xiapex
  • Active Comparator: Percutaneous needle fasciotomy
    PNF ad modum Lermusiaux and Debeyre
    Intervention: Procedure: Percutaneous needle fasciotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
  • Clearly defined strings

Exclusion Criteria:

  • Allergies to used medication
  • International Normalised Ratio more than 2.0
  • Pregnancy and breastfeeding
  • Previous treatment for DC in affected finger
  • Former inclusion in the study with another string
  • Activity in disease at time of study
  • PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01538017
M-20110233
No
Not Provided
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Jeppe Lange, MD, Regionshospitalet Silkeborg
Jeppe Lange, MD
Not Provided
Study Director: Jeppe Lange, M.D. Regionshospitalet Silkeborg
Regionshospitalet Silkeborg
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP