Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development