Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum

PHASE3TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

January 14, 2024

Study Completion Date

January 14, 2024

Conditions
Pyoderma Gangrenosum
Interventions
DRUG

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.

OTHER

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.

Trial Locations (1)

Unknown

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER

NCT05343754 - Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum | Biotech Hunter | Biotech Hunter