Ultrasound B Mode Imaging and Elastography (UBIEX-DC)

October 22, 2020 updated by: Theresa Bass-Goldman

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Normal Hand or Hand Dupuytren's contracture

Exclusion Criteria:

  • Previous treatment of Dupuytren's cord

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normals, Dupuytren's subjects with and without treatment
Ultrasound analysis of patient receiving treatment for Dupuytren's

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound B mode Imaging and Elastography
Time Frame: 30 day trial
A Pilot Study: Ultrasound B mode Imaging and Elastography during administration of Xiaflex
30 day trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theresa Bass-Goldman

Collaborators

Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 351-CRBR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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