NCT00261209

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

November 30, 2005

Last Update Submit

April 20, 2016

Conditions

Adhesion of Flexor Tendon of Hand

Keywords

Flexor Tendon AdhesionsZone II of the Hand

Outcome Measures

Primary Outcomes (1)

  • Restoration of PIP and DIP joint motion.

    6 months

Secondary Outcomes (1)

  • Hand Grip strength (kg)

    6 months

Study Arms (1)

Collagenase Injection

EXPERIMENTAL

Injection of collagenase into adhesion restricting tendon gliding

Drug: CollagenaseDrug: Collagenase injection

Interventions

CollagenaseDRUG

Collagenase injection into adhesion restricting tendon gliding

Also known as: Collagenase Clostridium Histolyticum
Collagenase Injection
Collagenase injectionDRUG

injection of collagenase into adhesion restricting tendon gliding

Also known as: Collagenase Clostridium Histolyticum
Collagenase Injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • zone II flexor tendon adhesion of at least one finger

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Interventions

CollagenasesMicrobial Collagenase

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)