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Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

Study acronym: DIONYSIUS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 8, 2024 (before its estimated May 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment target: estimated 544 to confirmed 30 Trial status: Recruiting to Active, Not Recruiting · Primary completion date: Dec 31, 2024 to May 1, 2025 · Completion date: Dec 31, 2026 to May 1, 2025 · 1 morev2 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 31, 2024 to May 1, 2025
    • Completion date: Dec 31, 2026 to May 1, 2025
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: \- What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.
Trial Details
NCT Number NCT05804097
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Peripheral Vascular Disease, Diabetic Foot Ulcer, Amputation
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov