Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

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

Completed

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Key information

Conditions

Dupuytrens Contracture Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Planned surgery - Regionalhospital Silkeborg

Silkeborg, 8600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xiapex

Drug

Collagenase Clostridium Histolyticum

Other names: XIAPEX® - Pfizer UK

Percutaneous needle fasciotomy

Procedure

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Primary outcomes

Clinical improvement

Time frame: 2 years

Clinical improvement is defined as a contracture reduction 50% or more from baseline.

Sponsors and collaborators

Lead sponsor

Jeppe Lange, MD

Other

Registry information

Official study title

Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Feb 23, 2012
Registry last updated: Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed