Trial record 1 of 1 for:    NCT01538017
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Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01538017
First received: February 18, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • Clinical improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Clinical improvement is defined as a contracture reduction 50% or more from baseline.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeppe Lange, MD, M:D:, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT01538017     History of Changes
Other Study ID Numbers: M-20110233
Study First Received: February 18, 2012
Last Updated: March 3, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on April 22, 2014