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

Dupuytren's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226121
• Other study ID #: IHtSC-Delay 101
• Status: Terminated
• Phase: Phase 4
• First received: October 20, 2010
• Last updated: May 16, 2014
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Indiana Hand to Shoulder Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Biological:
• Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection

Locations

Country	Name	City	State
United States	Indiana Hand to Shoulder Center	Indianaplis	Indiana
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Indiana Hand to Shoulder Center	Stony Brook University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)		30 days after injection	No
Secondary	Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)		90 days	No