NCT01226121

Brief Summary

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

October 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

June 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

October 20, 2010

Results QC Date

April 21, 2014

Last Update Submit

May 16, 2014

Conditions

Dupuytren's Disease

Keywords

dupuytrendupuytren's

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)

    30 days after injection

Secondary Outcomes (1)

  • Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)

    90 days

Study Arms (3)

Day 1 manipulation

ACTIVE COMPARATOR

Finger manipulation one day following Clostridial collagenase injectable

Biological: Clostridial collagenase injectable

Day 2 manipulation

ACTIVE COMPARATOR

Finger manipulation two days following Clostridial collagenase injectable

Biological: Clostridial collagenase injectable

Day 4 manipulation

ACTIVE COMPARATOR

Finger manipulation four days following Clostridial collagenase injectable

Biological: Clostridial collagenase injectable

Interventions

Clostridial collagenase injectableBIOLOGICAL

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Day 1 manipulationDay 2 manipulationDay 4 manipulation

Eligibility Criteria

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

You may qualify if:

  • Adult subjects (\> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of \> 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

You may not qualify if:

  • Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
  • Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
  • Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
  • Any subject with known allergy to Xiaflex (Clostridial collagenase).
  • Any subject who cannot conform to the study visit schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana Hand to Shoulder Center

Indianaplis, Indiana, 46260, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.

    PMID: 19726771BACKGROUND

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was terminated early due to slow enrollment

Results Point of Contact

Title
F. Thomas D. Kaplan
Organization
Indiana Hand to Shoulder Center
tdk@hand.md
3178759105

Study Officials

  • F. Thomas D. Kaplan, MD

    Indiana Hand to Shoulder Center

    PRINCIPAL INVESTIGATOR

  • Lawrence C Hurst, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 21, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 16, 2014

Results First Posted

June 16, 2014

Record last verified: 2014-05

Locations

US(2)