Injectable Collagenase and Percutaneous Needle Fasciotomy... | NCT01538017

Studies
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

NCT01538017

Sponsor

Jeppe Lange, MD

Status

Completed

Last Update Posted

Oct 4, 2016Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Dupuytrens Contracture

Interventions

Xiapex
Percutaneous needle fasciotomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Feb 18, 2012

First Submission Date that Met QC Criteria

Feb 18, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Xiapex	Drug	Collagenase Clostridium Histolyticum	Collagenase injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeppe Lange, M.D.	Regionshospitalet Silkeborg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Planned surgery - Regionalhospital Silkeborg		Silkeborg		8600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D004387	Dupuytren Contracture

Ancestor Terms

ID	Term
D005350	Fibroma
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570746	xiapex

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided