Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum

NCT05343754 | Terminated Phase 3

• 1 other identifier: NL 2021-006013-11
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• Wound healing time

  To compare the clinical efficacy of HBO treatment on top of standard regular wound care and anti-inflammatory treatment in patients with PG, with time to wound closure as the primary outcome, using a validated, objective 2D and 3D photographical wound measurement tools. Controls will be treated with regular wound care and anti-inflammatory treatment.

  3 months

Secondary Outcomes (5)

• Cytokines changes

  6 weeks

• mitochondrial O2 levels

  6 weeks

• Neutrophil count in peripheral venous blood

  6 weeks

• pain dairy

  3 months

• quality of life measurement

  1 year

Study Arms (2)

Hyperbaric Oxygen Therapy

ACTIVE COMPARATOR

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.

Drug: Hyperbaric oxygen

Control group

ACTIVE COMPARATOR

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.

Other: Control group

Interventions

Hyperbaric oxygen DRUG

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.

Also known as: breathing 100% oxygen under hyperbaric circumstances

Hyperbaric Oxygen Therapy

Control group OTHER

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.

Also known as: standard wound care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- Language barrier
• Unable to give informed consent or to comply with the trial protocol
• Pregnancy

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

Hyperbaric Oxygenation; Respiration; Control Groups

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Errol Prens, Prof.Dr.

  Erasmus MC, dermatology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients are aware of another treatment possibility (hyperbaric Oxygen therapy) which will be investigated.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pincipal investigator

Model Details: The study design is a pragmatic prospective cohort study: a group of patients with therapy refractory pyoderma gangrenosum despite standard wound care and anti-inflammatory treatment for at least 6 weeks will be treated with hyperbaric oxygen therapy.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)