What Researchers Did
Researchers designed the international DIONYSIUS trial to compare standard care alone versus standard care plus 20, 30, or at least 40 sessions of hyperbaric oxygen therapy for ischaemic diabetic foot ulcers.
What They Found
This study protocol outlines a plan to randomize patients with ischaemic diabetic foot ulcers into four groups: standard care alone or standard care combined with 0, 20, 30, or at least 40 sessions of hyperbaric oxygen therapy. The primary endpoint will be the major amputation rate after 12 months, with secondary endpoints including amputation-free survival, wound healing, health-related quality of life, and cost-effectiveness.
Canadian Relevance
This study protocol does not indicate any direct Canadian connection or participation.
Study Limitations
As a study protocol, this document outlines the design of a trial and does not present any completed research findings or patient outcomes.