Back to results

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Primary Purpose

Dupuytren's Disease

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Clostridial collagenase injectable

About this trial

This is an interventional treatment trial for Dupuytren's Disease focused on measuring dupuytren, dupuytren's

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Indiana Hand to Shoulder Center
Stony Brook University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Day 1 manipulation

Day 2 manipulation

Day 4 manipulation

Arm Description

Finger manipulation one day following Clostridial collagenase injectable

Finger manipulation two days following Clostridial collagenase injectable

Finger manipulation four days following Clostridial collagenase injectable

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01226121

First Posted

October 20, 2010

Last Updated

May 16, 2014

Sponsor

Indiana Hand to Shoulder Center

Collaborators

Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT01226121

Brief Title

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Official Title

A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

difficulty enrolling additional patients

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana Hand to Shoulder Center

Collaborators

Stony Brook University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dupuytren's Disease

Keywords

dupuytren, dupuytren's

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Day 1 manipulation

Arm Type

Active Comparator

Arm Description

Finger manipulation one day following Clostridial collagenase injectable

Arm Title

Day 2 manipulation

Arm Type

Active Comparator

Arm Description

Finger manipulation two days following Clostridial collagenase injectable

Arm Title

Day 4 manipulation

Arm Type

Active Comparator

Arm Description

Finger manipulation four days following Clostridial collagenase injectable

Intervention Type

Biological

Intervention Name(s)

Clostridial collagenase injectable

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

30 days after injection

Secondary Outcome Measure Information:

Title

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

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

F. Thomas D. Kaplan, MD

Organizational Affiliation

Indiana Hand to Shoulder Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lawrence C Hurst, MD

Organizational Affiliation

Stony Brook University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana Hand to Shoulder Center

City

Indianaplis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Stony Brook University

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19726771

Citation

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.

Results Reference

background

Learn more about this trial

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

We'll reach out to this number within 24 hrs