Hyperbaric Oxygen Therapy for Pyoderma gangrenosum As a New Treatment Strategy
Phase 3
Recruiting
- Conditions
- Pyoderma gangrenosumdermatitis ulcerosa1002766510040790
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the clinical effectiveness in wound healing time (full<br /><br>re-epithelialization) and to confirm the hypothesis the feasibility and<br /><br>possible efficacy of hyperbaric oxygen therapy in patients with pyoderma<br /><br>gangrenosum refractory to standard prednisone therapy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Changes in markers of inflammation, mRNA expression in micro-biopsies in<br /><br>wound edges.<br /><br>- Alterations in mitochondrial O2 levels<br /><br>- The number of activated neutrophils in peripheral venous blood.<br /><br>- To assess the effect of HBOT on Pain reduction (NRS score).<br /><br>- To assess the effect of HBOT on Health Related-Quality of Life (WOUND-Q).<br /><br>- To assess the prevalence of recurrence of PG in patients treated with and<br /><br>without adjuvant HBOT.</p><br>