Clinical Trial

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

Study acronym: DIONYSIUS
Active, Not Recruiting Phase 4
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.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-04-05.
Status change: Recruiting → Active, Not Recruiting 2024-11-07
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 2021-10-08
Primary Completion 2025-05-01 (estimated)
Study Completion 2025-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-08