Pyoderma gangrenosum
Conditions
Interventions
30 sessions of HBO therapy at 2.4-2.5 atmosphere absolute in addition to
treatment conform clinical practice. Controls will be treated according to
clinical practice.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: • Language barrier • Unable to give informed consent - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical effectiveness in wound healing time (full re-epithelialization) and to confirm the hypothesis the feasibility and possible efficacy of hyperbaric oxygen therapy in patients with pyoderma gangrenosum refractory to standard prednisone therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in markers of inflammation, mRNA expression in micro-biopsies in wound edges. - Alterations in mitochondrial O2 levels - The number of activated neutrophils in peripheral venous blood. - To assess the effect of HBOT on Pain reduction (NRS score). - To assess the effect of HBOT on Health Related-Quality of Life (WOUND-Q). - To assess the prevalence of recurrence of PG in patients treated with and without adjuvant HBOT. | — |
Countries
Netherlands
Outcome results
None listed