Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum (HOTPANTS)
Pyoderma Gangrenosum
About this trial
This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Hyperbaric Oxygen Therapy
Eligibility Criteria
Inclusion Criteria:
- - Confirmed consensus on the diagnosis pyoderma gangrenosum by referring specialist, principal and coordinating investigator (dermatologist, clinical immunologist or rheumatologist based on PARACELSUS and Delphi score).
- Unsatisfactory response after six weeks of combined standard wound care and systemic prednisone and/or other anti-inflammatory therapy.
- Fit for hyperbaric oxygen therapy as assessed by the hyperbaric physician.
- Age ≥18 years at baseline
- All genders
- Able and willing to give written informed consent and to comply with the study requirements.
Exclusion Criteria:
- - Language barrier
- Unable to give informed consent or to comply with the trial protocol
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Hyperbaric Oxygen Therapy
Control group
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 80 minutes (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.
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.