Clinical trial NCT05877066: Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Official title: Generating Real-world Ambispective Data to Study Participant Treatment Outcomes for Dupuytren's Contracture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dupuytren's Contracture
Keywords: Real world data
Retrospective
Prospective
Registry
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pulse InfoFrame
First posted: 2023-05-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of DC will be enrolled in the United States.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Receiving Each Treatment Type for DC
timeFrame: Up to 36 months
Secondary outcomes:
measure: Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score
timeFrame: Up to 36 months
measure: Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score
timeFrame: Up to 36 months
measure: Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score
timeFrame: Up to 36 months
measure: Participant Satisfaction Questionnaire
timeFrame: Up to 36 months
measure: Number of Participants Receiving Post-Procedural Care by the Treating Physician
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Endo Pharmaceuticals Clinical Site 6
state: Arizona
city: Greenwich
country: United States
facility: Endo Pharmaceuticals Clinical Site 5
state: Connecticut
city: Temple Terrace
country: United States
facility: Endo Pharmaceuticals Clinical Site 4
state: Florida
city: Indianapolis
country: United States
facility: Endo Pharmaceuticals Clinical Site 2
state: Indiana
city: Eatontown
country: United States
facility: Endo Pharmaceuticals Clinical Site 1
state: New Jersey
city: Charlotte
country: United States
facility: Endo Pharmaceuticals Clinical Site 7
state: North Carolina
city: Bend
country: United States
facility: Endo Pharmaceuticals Clinical Site 3
state: Oregon
Study officials:
affiliation: Endo Pharmaceuticals
name: Medical Information
role: STUDY_DIRECTOR
References: