NCT01538017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

4.7 years

First QC Date

February 18, 2012

Last Update Submit

October 3, 2016

Conditions

Dupuytrens Contracture

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

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

    2 years

Study Arms (2)

Collagenase injection

ACTIVE COMPARATOR

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Drug: Xiapex

Percutaneous needle fasciotomy

ACTIVE COMPARATOR

PNF ad modum Lermusiaux and Debeyre

Procedure: Percutaneous needle fasciotomy

Interventions

XiapexDRUG

Collagenase Clostridium Histolyticum

Also known as: XIAPEX® - Pfizer UK
Collagenase injection
Percutaneous needle fasciotomyPROCEDURE

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
  • Clearly defined strings

You may not qualify if:

  • Allergies to used medication
  • International Normalised Ratio more than 2.0
  • Pregnancy and breastfeeding
  • Previous treatment for DC in affected finger
  • Activity in disease at time of study
  • PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Planned surgery - Regionalhospital Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

xiapex

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeppe Lange, M.D.

    Regionshospitalet Silkeborg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M:D:

Study Record Dates

First Submitted

February 18, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

DK(1)