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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014