Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

NCT ID: NCT01538017

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-10-31

Brief Summary

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

Detailed Description

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Conditions

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Dupuytrens Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Collagenase injection

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Group Type ACTIVE_COMPARATOR

Xiapex

Intervention Type DRUG

Collagenase Clostridium Histolyticum

Percutaneous needle fasciotomy

PNF ad modum Lermusiaux and Debeyre

Group Type ACTIVE_COMPARATOR

Percutaneous needle fasciotomy

Intervention Type PROCEDURE

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Interventions

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Xiapex

Collagenase Clostridium Histolyticum

Intervention Type DRUG

Percutaneous needle fasciotomy

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Intervention Type PROCEDURE

Other Intervention Names

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XIAPEX® - Pfizer UK

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeppe Lange, MD

OTHER

Sponsor Role lead

Responsible Party

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Jeppe Lange, MD

M:D:

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeppe Lange, M.D.

Role: STUDY_DIRECTOR

Regionshospitalet Silkeborg

Locations

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Center for Planned surgery - Regionalhospital Silkeborg

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20110233

Identifier Type: -

Identifier Source: org_study_id

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