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

Endo Pharmaceuticals130 enrolled

Overview

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.

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

130

Conditions

Dupuytren's Contracture

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Endo Pharmaceuticals Clinical Site 6

Phoenix, Arizona, United States

Endo Pharmaceuticals Clinical Site 5

Greenwich, Connecticut, United States

Endo Pharmaceuticals Clinical Site 4

Temple Terrace, Florida, United States

Endo Pharmaceuticals Clinical Site 2

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Number of Participants Receiving Each Treatment Type for DC

Time frame: Up to 36 months

Secondary Outcomes

Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score

Time frame: Up to 36 months

Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score

Time frame: Up to 36 months

Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score

Time frame: Up to 36 months

Participant Satisfaction Questionnaire

Time frame: Up to 36 months

Number of Participants Receiving Post-Procedural Care by the Treating Physician

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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