Collagenase in the Treatment of Zone II Flexor Tendon Adh... | NCT00261209

Studies
Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand

NCT00261209

Sponsor

Stony Brook University

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

3Actual

Phase

Phase 1Phase 2

Conditions

Adhesion of Flexor Tendon of Hand

Interventions

Collagenase
Collagenase injection

Countries

United States

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

Apr 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

Jan 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Nov 30, 2005

First Posted Date

Dec 2, 2005Estimated

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

Apr 20, 2016

Last Update Posted Date

Apr 21, 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

The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.

Detailed Description

In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.

Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Collagenase Injection	Experimental	Injection of collagenase into adhesion restricting tendon gliding	Drug: Collagenase Drug: Collagenase injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collagenase	Drug	Collagenase injection into adhesion restricting tendon gliding	Collagenase Injection

Measure	Description	Time Frame
Restoration of PIP and DIP joint motion.		6 months

Measure	Description	Time Frame
Hand Grip strength (kg)		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

zone II flexor tendon adhesion of at least one finger

Exclusion Criteria:

any chronic, serious or uncontrolled medical condition
inability to conform to study visits (12-15 per year)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Marie A Badalamente, PhD	Dept. Orthopaedics, SUNY@Stony Brook, NY 11794	Principal Investigator
Edward Wang, MD	Dept. Orthopaedics, SUNY@Stony Brook, NY 11794	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Orthopaedics, SUNY@Stony Brook		Stony Brook	New York	11794	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017364	Collagenases
D003012	Microbial Collagenase

Ancestor Terms

ID	Term
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

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Browse Branches

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