Dupuytren's Disease
Conditions
Keywords
Dupuytren's Contracture
Brief summary
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
Detailed description
Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.
Interventions
BIOLOGICALXIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Sponsors
Auxilium Pharmaceuticals, Inc.
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger. * Subject has only one finger affected by the disease. * Patients will be 35 years of age of older. * Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.
Exclusion criteria
* Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase. * Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands. * Patient has known allergy to collagenase or any other excipient of Xiaflex. * Patient has received any collagenase treatments before the first dose of Xiaflex. * Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. | Baseline and 30 days | Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from July 2011 to December 2011. Enrollment was completed in a medical clinic.
Participants by arm
| Arm | Count |
|---|---|
| XIAFLEX Patient who have received XIAFLEX | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | XIAFLEX |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 67.6 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.
Time frame: Baseline and 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| XIAFLEX | The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. | 482 mm^3 |
p-value: <0.0013t-test, 2 sided