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

Phase 4TerminatedNCT01226121

Indiana Hand to Shoulder Center37 enrolled

Overview

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.

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,

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dupuytren's Disease

Interventions

Clostridial collagenase injectableBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Indiana Hand to Shoulder Center

Indianaplis, Indiana, United States

Stony Brook University

Stony Brook, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days after injection

Secondary Outcomes

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

Time frame: 90 days

Data from ClinicalTrials.gov

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