Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
- Conditions
- Dupuytren's Contracture
- Registration Number
- NCT05877066
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 130
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Receiving Each Treatment Type for DC Up to 36 months
- Secondary Outcome Measures
Name Time Method Participant Satisfaction Questionnaire Up to 36 months 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 Number of Participants Receiving Post-Procedural Care by the Treating Physician Up to 36 months
Trial Locations
- 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
Endo Pharmaceuticals Clinical Site 1
🇺🇸Eatontown, New Jersey, United States
Endo Pharmaceuticals Clinical Site 7
🇺🇸Charlotte, North Carolina, United States
Endo Pharmaceuticals Clinical Site 3
🇺🇸Bend, Oregon, United States
Endo Pharmaceuticals Clinical Site 6🇺🇸Phoenix, Arizona, United States