Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

Dupuytren's Contracture Clinical Trial

Official title:

The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265420
• Other study ID #: IHtSC-Thumb 101
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2010
• Last updated: April 8, 2015
• Start date: December 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• 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

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• 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 MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb

• First web space contracture with a palpable cord due to Dupuytren's contracture

Exclusion Criteria:

• Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.

• 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).

• Pregnant or nursing female

• Any subject who cannot conform to the study visit schedule

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Intervention

Biological:
• Injectable clostridial collagenase
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Locations

Country	Name	City	State
United States	Indiana Hand to Shoulder Center	Indianaplis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Hand to Shoulder Center

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	Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)		30 days after last injection	No