3
Participants
Start Date
June 1, 2022
Primary Completion Date
January 14, 2024
Study Completion Date
January 14, 2024
Hyperbaric oxygen
Hyperbaric treatment will consist of 30 daily treatments in the first 6 weeks of the study, except during the weekends. After compression for 10 minutes patients will receive 80minutes (4 times 20 minutes) 100% O2 with 3 airbrakes (21% O2) of 5 minutes at 2.4-2.5 ATA, and then 10 minutes decompression with the first part of decompression till 0.3 ATA with 100% oxygen (this will usually take seven minutes). The last 0.3 ATA will be decompressed with air. In total one hyperbaric session will be 110 minutes. Treatment will start directly at the beginning of the study.
Control group
In order to compare efficacy, patients that do not wish to undergo hyperbaric treatment, will serve as a control group. At baseline they will be asked for the reason they do not wish to undergo hyperbaric treatment. All patients and controls will be asked to report pain scores using a numeric pain rating scale (NRS) and quality of life (Wound-Q) questionnaires. They will continue to receive standard care as deemed necessary by their primary physician.
Erasmus MC, Rotterdam
Lead Sponsor
Erasmus Medical Center
OTHER