Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

NCT ID: NCT05877066

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-14

Study Completion Date

2024-02-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dupuytren's Contracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pulse Infoframe

INDUSTRY

Sponsor Role collaborator

Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Information

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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Endo Pharmaceuticals Clinical Site 6

Phoenix, Arizona, United States

Site Status

Endo Pharmaceuticals Clinical Site 5

Greenwich, Connecticut, United States

Site Status

Endo Pharmaceuticals Clinical Site 4

Temple Terrace, Florida, United States

Site Status

Endo Pharmaceuticals Clinical Site 2

Indianapolis, Indiana, United States

Site Status

Endo Pharmaceuticals Clinical Site 1

Eatontown, New Jersey, United States

Site Status

Endo Pharmaceuticals Clinical Site 7

Charlotte, North Carolina, United States

Site Status

Endo Pharmaceuticals Clinical Site 3

Bend, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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EP01REG

Identifier Type: -

Identifier Source: org_study_id

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