MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Sponsors
Source
Hospital for Special Surgery, New York
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2011-03-01
Completion Date
2012-02-01
Primary Completion Date
2012-01-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. |
Baseline and 30 days |
Enrollment
5
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Arm Group Label
XIAFLEX
Other Name
Collagenase
Eligibility
Criteria
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.
Gender
All
Minimum Age
35 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Scott W Wolfe, MD |
Principal Investigator |
Hospital for Special Surgery, New York |
Location
Facility |
|
Hosptial for Special Surgery New York New York 10021 United States |
Location Countries
Country
United States
Verification Date
2017-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
XIAFLEX
Arm Group Type
Other
Description
XIAFlEX
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
October 10, 2011
Study First Submitted Qc
October 11, 2011
Study First Posted
October 12, 2011
Last Update Submitted
March 20, 2017
Last Update Submitted Qc
March 20, 2017
Last Update Posted
April 17, 2017
Results First Submitted
October 29, 2013
Results First Submitted Qc
April 14, 2014
Results First Posted
May 15, 2014
ClinicalTrials.gov processed this data on August 29, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.