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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538017

Enrollment

Registered

2012-02-23

Start date

2012-02-29

Completion date

2016-10-31

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytrens Contracture

Brief summary

Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Interventions

PROCEDUREPercutaneous needle fasciotomy

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

DRUGXiapex

Collagenase Clostridium Histolyticum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026