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

NCT05877066 — Terminated, 130 participants, Endo USA Inc., a Keenova Therapeutics Company

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

RegistryNCT05877066, acronym GRASP-DC
StatusTerminated - Endo determined to discontinue its registries and the GRASP registry enrollment has been closed.
Study typeObservational
Enrollment130 (Actual)
SponsorEndo USA Inc., a Keenova Therapeutics Company (Industry); collaborators: Pulse Infoframe
ConditionsDupuytren's Contracture
Datesstart 2023-06-14, primary completion 2024-02-26, completion 2024-02-26, first posted 2023-05-26, last updated 2024-04-16
Locations7 sites in United States

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-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.

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+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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • 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

Sex: All, ages: 18 Years to any

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.

+Locations (7)

FacilityCityCountryStatus
Endo Pharmaceuticals Clinical Site 6Phoenix, ArizonaUnited States
Endo Pharmaceuticals Clinical Site 5Greenwich, ConnecticutUnited States
Endo Pharmaceuticals Clinical Site 4Temple Terrace, FloridaUnited States
Endo Pharmaceuticals Clinical Site 2Indianapolis, IndianaUnited States
Endo Pharmaceuticals Clinical Site 1Eatontown, New JerseyUnited States
Endo Pharmaceuticals Clinical Site 7Charlotte, North CarolinaUnited States
Endo Pharmaceuticals Clinical Site 3Bend, OregonUnited States

+Investigators

  • Medical Information, Study director, Endo USA Inc., a Keenova Therapeutics Company