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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05877066

Acronym

GRASP-DC

Enrollment

130

Registered

2023-05-26

Start date

2023-06-14

Completion date

2024-02-26

Last updated

2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's Contracture

Keywords

Real world data, Retrospective, Prospective, Registry

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants Receiving Each Treatment Type for DC	Up to 36 months

Secondary

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

Countries

United States

Outcome results