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

NCT05877066 | Terminated

• 1 other identifier: EP01REG
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 7

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.

Conditions

Dupuytren's Contracture

Keywords

Real world data; Retrospective; Prospective; Registry

Outcome Measures

Primary Outcomes (1)

• Number of Participants Receiving Each Treatment Type for DC

  Up to 36 months

Secondary Outcomes (5)

• 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a confirmed diagnosis of DC will be enrolled in the United States.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• Pulse Infoframe: collaborator

Study Sites (7)

Endo Pharmaceuticals Clinical Site 6

Phoenix, Arizona, 85015, United States

Location

Endo Pharmaceuticals Clinical Site 5

Greenwich, Connecticut, 06831, United States

Location

Endo Pharmaceuticals Clinical Site 4

Temple Terrace, Florida, 33637, United States

Location

Endo Pharmaceuticals Clinical Site 2

Indianapolis, Indiana, 46260, United States

Location

Endo Pharmaceuticals Clinical Site 1

Eatontown, New Jersey, 07774, United States

Location

Endo Pharmaceuticals Clinical Site 7

Charlotte, North Carolina, 28207, United States

Location

Endo Pharmaceuticals Clinical Site 3

Bend, Oregon, 97701, United States

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Information

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: June 14, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (7)