A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
Validation of Two New Questionnaires for Dupuytren's Disease
Sponsors
Source
Hospital for Special Surgery, New York
Oversight Info
Has Dmc
No
Brief Summary
A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective
is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are
standard and validated questionnaire instruments used to measure health related quality of
life and function, they do not address patient specific issues. The investigators will also
pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's
Disease.
Overall Status
Unknown status
Start Date
2011-02-01
Completion Date
2015-12-01
Primary Completion Date
2015-12-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
QuickDASH (Disability of the Arm, Shoulder, and Hand) |
30 day follow up |
Enrollment
80
Condition
Eligibility
Study Pop
Patients receiving treatment with XIAFLEX for Dupuytren's Disease
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- Subject has a diagnosis of Dupuytren's Disease in at least one finger
- Patients will be 35 years of age or older
- Patients will be able to read, speak, and understand English
- Patients will 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 a known allergy to collagenase or any other excipient of XIAFLEX.
- Patient has received any collagenase treatments before the first dose of XIAFLEX.
- Any history of or current medical condition which in the investigator's opinion would
make the subject unsuitable for enrollment in the study
Gender
All
Minimum Age
35 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Robert N Hotchkiss, MD |
Principal Investigator |
Hosptial for Special Surgery |
Location
Facility |
|
Hospital For Special Surgery New York New York 10021 United States |
Location Countries
Country
United States
Verification Date
2015-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Hospital for Special Surgery, New York
Investigator Full Name
Robert Hotchkiss
Investigator Title
MD
Keyword
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
October 3, 2011
Study First Submitted Qc
October 4, 2011
Study First Posted
October 5, 2011
Last Update Submitted
April 1, 2015
Last Update Submitted Qc
April 1, 2015
Last Update Posted
April 3, 2015
Last Known Status
Active, not recruiting
ClinicalTrials.gov processed this data on August 31, 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.