Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture (GRASP-DC)

April 13, 2024 updated by: Endo Pharmaceuticals

Generating Real-world Ambispective Data to Study Participant Treatment Outcomes for Dupuytren's Contracture

This is an observational study, meaning participants will not receive any investigational treatment as part of this study.

Researchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.

Study Overview

Status

Terminated

Conditions

Detailed Description

Each participant of the study will have their data collected from the date of confirmed diagnosis of DC to the date of enrollment in the registry, post consent. Data will be collected from the participants clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.

Study Type

Observational

Enrollment (Actual)

130

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
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Endo Pharmaceuticals Clinical Site 6
    • Connecticut
      • Greenwich, Connecticut, United States, 06831
        • Endo Pharmaceuticals Clinical Site 5
    • Florida
      • Temple Terrace, Florida, United States, 33637
        • Endo Pharmaceuticals Clinical Site 4
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Endo Pharmaceuticals Clinical Site 2
    • New Jersey
      • Eatontown, New Jersey, United States, 07774
        • Endo Pharmaceuticals Clinical Site 1
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Endo Pharmaceuticals Clinical Site 7
    • Oregon
      • Bend, Oregon, United States, 97701
        • Endo Pharmaceuticals Clinical Site 3

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a confirmed diagnosis of DC will be enrolled in the United States.

Description

Key Inclusion Criteria:

  • Any adult with a confirmed clinical diagnosis of DC.
  • Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.
  • Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.
  • Having received DC treatment, either non-surgical or surgical, within 2 weeks before enrollment, at enrollment or any time after the date of enrollment or not having received DC treatment after confirmed diagnosis of DC.
  • Able to participate in English based registry.

Key Exclusion criteria:

  • Not having a clinical diagnosis of DC.
  • Age less than 18 years.
  • Do not provide informed consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Receiving Each Treatment Type for DC
Time Frame: Up to 36 months
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score
Time Frame: Up to 36 months
Up to 36 months
Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score
Time Frame: Up to 36 months
Up to 36 months
Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score
Time Frame: Up to 36 months
Up to 36 months
Participant Satisfaction Questionnaire
Time Frame: Up to 36 months
Up to 36 months
Number of Participants Receiving Post-Procedural Care by the Treating Physician
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

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

Sponsor

Endo Pharmaceuticals

Collaborators

Pulse Infoframe

Investigators

  • Study Director: Medical Information, 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)

June 14, 2023

Primary Completion (Actual)

February 26, 2024

Study Completion (Actual)

February 26, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP01REG

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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