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

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05877066

Collaborator

Pulse InfoFrame (Other)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dupuytren's Contracture

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

Number of Participants Receiving Each Treatment Type for DC [Up to 36 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.