Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

This study is currently recruiting participants.

Verified February 2012 by Regionshospitalet Silkeborg

Sponsor:

Information provided by (Responsible Party):

Jeppe Lange, MD, Regionshospitalet Silkeborg

ClinicalTrials.gov Identifier:

NCT01538017

First received: February 18, 2012

Last updated: NA

Last verified: February 2012

History: No changes posted

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

Resource links provided by NLM:

Drug Information available for: Collagenase

U.S. FDA Resources

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:	January 2015
Estimated Primary Completion Date:	January 2014 (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

Contacts

Contact: Simon T Skov, M.D.	+45 87222473	silkeborg.ko-projekt@rm.dk
Contact: Jeppe Lange, M.D.		jeppe.lange@ki.au.dk

Locations

Denmark
Center for Planned surgery - Regionalhospital Silkeborg	Recruiting
Silkeborg, Denmark, 8600
Principal Investigator: Simon T Skov, M.D.

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:	February 18, 2012
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 June 18, 2013

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