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Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538017
First Posted: February 23, 2012
Last Update Posted: October 4, 2016
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.
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
  Purpose
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Condition Intervention
Dupuytrens Contracture Drug: Xiapex Procedure: Percutaneous needle fasciotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jeppe Lange, MD, Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • Clinical improvement [ Time Frame: 2 years ]
    Clinical improvement is defined as a contracture reduction 50% or more from baseline.


Enrollment: 50
Study Start Date: February 2012
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collagenase injection
Injection of collagenase obtained from Clostridium Histolyticum in contracture string
Drug: Xiapex
Collagenase Clostridium Histolyticum
Other Name: XIAPEX® - Pfizer UK
Active Comparator: Percutaneous needle fasciotomy
PNF ad modum Lermusiaux and Debeyre
Procedure: Percutaneous needle fasciotomy
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01538017


Locations
Denmark
Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Jeppe Lange, MD
Investigators
Study Director: Jeppe Lange, M.D. Regionshospitalet Silkeborg
  More Information

Responsible Party: Jeppe Lange, MD, M:D:, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT01538017     History of Changes
Other Study ID Numbers: M-20110233
First Submitted: February 18, 2012
First Posted: February 23, 2012
Last Update Posted: October 4, 2016
Last Verified: October 2016

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


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