Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Pyoderma gangrenosum (PG) is a rare auto-inflammatory neutrophilic dermatosis
characterized by a spectrum of clinical presentations with variable courses. Diagnosis and
management are challenging in PG. Treatment, including systemic prednisone and anti-TNF
therapy, is directed towards reducing pain and associated inflammation that leads to
ulceration. Positive effects of hyperbaric oxygen (HBO) therapy have been reported in small
case series.
Objective: To investigate the therapeutic efficacy of hyperbaric oxygen on top of standard
wound care and regular anti-inflammatory treatment in patients with pyoderma gangrenosum
wounds.
Study design: Prospective cohort study with a follow-up to one year. Study population: 15
adult patients with pyoderma gangrenosum refractory to standard-prednisone or anti-TNF
therapy will be included for hyperbaric oxygen therapy. Patients with pyoderma gangrenosum
that are eligible but reject hyperbaric oxygen treatment will serve as controls. In total we
will include 30 patients.
Intervention (if applicable): 30 sessions of HBO therapy will be applied on top of regular
wound care and systemic anti-inflammatory treatment. Controls will be treated with regular
wound care and anti-inflammatory treatment.
Main study parameters/endpoints: Wound healing time (time to wound closure). PG wounds will
be measured at baseline using a validated, objective 3D photographical wound measurement
tool, and again after 3 and 6 weeks at the end of HBO treatment and after 3 months. Patients
will take weekly photographs at home using a 2D validated measurement tool of the wounds.
Secondary parameters: Alteration in the expression of markers of inflammation by
micro-biopsies of wound edges, non-invasive mitochondrial O2 measurements at wound edges,
blood neutrophil count and patient-reported outcomes like WOUND-Q, pain on NR scale and
treatment satisfaction scores. Assessment concerning laboratory findings will be done at
baseline before starting the trial, at 3 weeks and at week 6 at the end of HBO treatment.
Patient reported outcomes, WOUND-Q will be measured at baseline, 3 weeks, 6 weeks, 3 months,
6 months, and 12 months. Mean NRS scores will be recorded once a week.