Dupuytren's DiseaseNCT01446432
Validation of Two New Questionnaires for Dupuytren's Disease
An observational study of Dupuytren's Disease, run by Robert Hotchkiss at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Dupuytren's Disease
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving treatment with XIAFLEX for Dupuytren's Disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital For Special Surgery
New York, New York, 10021
About this study
Official title: A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
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.
- Conditions
- Dupuytren's Disease
- Keywords
- Dupuytren's Contracture
- Medical subject headings
- Dupuytren Contracture
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH (Disability of the Arm, Shoulder, and Hand)
Measured: 30 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Hotchkiss
- Sponsor type
- University, hospital or other
- Collaborators
- Auxilium Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Robert Hotchkiss, Hospital for Special Surgery, New York
- Investigators
- Robert N Hotchkiss, MD, Principal investigator, Hosptial for Special Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446432
- Sponsor's protocol ID
- 11011
- Status last verified
- Apr 2015
- First submitted
- 3 Oct 2011
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
- ClinicalTrials.gov ID
- NCT01446432
- Acronym / sponsor ID
- 11011
- Conditions
- Dupuytren's Disease
- Keywords
- Dupuytren's Contracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Robert HotchkissUniversity, hospital or other
- Collaborators
- Auxilium Pharmaceuticals, Inc.
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment with XIAFLEX for Dupuytren's Disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QuickDASH (Disability of the Arm, Shoulder, and Hand)
Time frame: 30 day follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert N Hotchkiss, MD principal investigator
Hosptial for Special Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Robert Hotchkiss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH (Disability of the Arm, Shoulder, and Hand) (time frame: 30 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.