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

NCT ID: NCT01265420

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Dupuytren's Contracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injectable clostridial collagenase

Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase

Group Type: EXPERIMENTAL

Injectable clostridial collagenase

Intervention Type: BIOLOGICAL

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

Interventions

Injectable clostridial collagenase

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Xiaflex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana Hand to Shoulder Center

OTHER

Sponsor Role: lead

Responsible Party

F. Thomas D. Kaplan, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana Hand to Shoulder Center

Indianaplis, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19726771 (View on PubMed)

Other Identifiers

IHtSC-Thumb 101

Identifier Type: -

Identifier Source: org_study_id