Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

October 3, 2016 updated by: Jeppe Lange, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Silkeborg, Denmark, 8600
        • Center for Planned surgery - Regionalhospital Silkeborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Collagenase injection
Injection of collagenase obtained from Clostridium Histolyticum in contracture string
Drug: Xiapex
Collagenase Clostridium Histolyticum
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 2 years
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeppe Lange, MD

Investigators

  • Study Director: Jeppe Lange, M.D., Regionshospitalet Silkeborg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 18, 2012

First Submitted That Met QC Criteria

February 18, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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