Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum

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 the investigators 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.

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.

Sponsors & Collaborators

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Errol Prens, Prof.Dr. · Erasmus MC, dermatology department

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2024-01-14

Completion

2024-01-14

Countries

• Netherlands

Study Locations