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

Dupuytren's Contracture Clinical Trial

— GRASP-DC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05877066
• Other study ID #: EP01REG
• Status: Terminated
• Start date: June 14, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: April 2024
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Locations

Country	Name	City	State
United States	Endo Pharmaceuticals Clinical Site 3	Bend	Oregon
United States	Endo Pharmaceuticals Clinical Site 7	Charlotte	North Carolina
United States	Endo Pharmaceuticals Clinical Site 1	Eatontown	New Jersey
United States	Endo Pharmaceuticals Clinical Site 5	Greenwich	Connecticut
United States	Endo Pharmaceuticals Clinical Site 2	Indianapolis	Indiana
United States	Endo Pharmaceuticals Clinical Site 6	Phoenix	Arizona
United States	Endo Pharmaceuticals Clinical Site 4	Temple Terrace	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	Pulse InfoFrame

Country where clinical trial is conducted

United States, 

Outcome

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