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

Indiana Hand to Shoulder Center

Status and phase: Terminated; Phase 4

Conditions: Dupuytren's Disease

Treatments: Biological: Clostridial collagenase injectable

Study type: Interventional

Funder types: Other

Identifiers

NCT01226121

IHtSC-Delay 101

Details and patient eligibility

About

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.

Full 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,

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

Day 1 manipulation

Active Comparator group

Description:

Finger manipulation one day following Clostridial collagenase injectable

Treatment:

Biological: Clostridial collagenase injectable

Day 2 manipulation

Active Comparator group

Description:

Finger manipulation two days following Clostridial collagenase injectable

Treatment:

Biological: Clostridial collagenase injectable

Day 4 manipulation

Active Comparator group

Description:

Finger manipulation four days following Clostridial collagenase injectable

Treatment:

Biological: Clostridial collagenase injectable