Dupuytren's ContracturesUBIEX-DCNCT04607187
Ultrasound B Mode Imaging and Elastography
An observational study of Dupuytren's Contractures, run by Theresa Bass-Goldman at 1 site in United States.
Trial summary
A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dupuytren's Contractures
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2014
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups of people will take part in the research: 5-Normal subjects without a Dupuytren's contracture 5-Subjects that have a hand Dupuytren's contracture that will not receive tx 10-Subjects that have a hand Dupuytren's contracture that will receive tx
Who may be able to join
- Normal Hand or Hand Dupuytren's contracture
Who cannot join
- Previous treatment of Dupuytren's cord
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
Wheaton, Maryland, 20902
About this study
Official title: Ultrasound B Mode Imaging and Elastography During Administration of Xiaflex (Collagenase Clostridium Histolyticum) for Dupuytren's Contracture: A Pilot Study (The UBIEX-DC Study)
A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture.
Read the detailed description
Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture
- Conditions
- Dupuytren's Contractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normals, Dupuytren's subjects with and without treatment | Ultrasound analysis of patient receiving treatment for Dupuytren's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound B mode Imaging and Elastography
A Pilot Study: Ultrasound B mode Imaging and Elastography during administration of Xiaflex
Measured: 30 day trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study startNov 2013
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's ContracturesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresa Bass-Goldman
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor-investigator, Theresa Bass-Goldman, Arthritis & Rheumatism Associates, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607187
- Sponsor's protocol ID
- 351-CRBR
- Acronym
- UBIEX-DC
- Status last verified
- Oct 2020
- First submitted
- 22 Nov 2013
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound B Mode Imaging and Elastography During Administration of Xiaflex (Collagenase Clostridium Histolyticum) for Dupuytren's Contracture: A Pilot Study (The UBIEX-DC Study)
- ClinicalTrials.gov ID
- NCT04607187
- Acronym / sponsor ID
- UBIEX-DC / 351-CRBR
- Conditions
- Dupuytren's Contractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Theresa Bass-GoldmanUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2020 (actual)
- 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 Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture.
Detailed description
Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals, Dupuytren's subjects with and without treatment | – | –Ultrasound analysis of patient receiving treatment for Dupuytren's |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of people will take part in the research: 5-Normal subjects without a Dupuytren's contracture 5-Subjects that have a hand Dupuytren's contracture that will not receive tx 10-Subjects that have a hand Dupuytren's contracture that will receive tx
Key inclusion criteria (1 listed)
- Normal Hand or Hand Dupuytren's contracture
Key exclusion criteria (1 listed)
- Previous treatment of Dupuytren's cord
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
Ultrasound B mode Imaging and Elastography
Time frame: 30 day trial
A Pilot Study: Ultrasound B mode Imaging and Elastography during administration of Xiaflex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Contractures, run by Theresa Bass-Goldman 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasound B mode Imaging and Elastography (time frame: 30 day trial). 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 29 Oct 2020.