NCT07240649

Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

Emerging Indications for Hyperbaric Oxygen Treatment

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jay C. Buckey Jr. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Detailed description

Currently, the Undersea and Hyperbaric Medical Society (UHMS) has identified 15 conditions where HBO2 can be considered an approved treatment. These range from decompression illness, where the combination of increased pressure, relief of hypoxia, and reduced inflammation from HBO2 help combat the impaired circulation and endothelial damage caused by bubbles, to radiation injury, where the pulses of oxygen promote angiogenesis and wound healing. Because of HBO2's effects on hypoxia and inflammation, more medical diagnoses exist that can benefit from HBO2. HBO2 is typically given in long courses (20-40 treatments), however, and most centers see only a limited number of patients. Therefore, gathering outcome data on HBO2 treatment has been limited, and often, only case reports or small case series are available to support its use. In addition, practice patterns differ across centers, and some centers may use HBO2 successfully for an indication that other centers may not consider it for. To gather more data on HBO2 applications, outcome data from multiple centers need to be combined. The goal of the Multicenter Registry for Hyperbaric Oxygen Treatment is to collect and aggregate these data. In a recent publication from our group, we presented data for 45 emerging indications for hyperbaric oxygen treatment. A unifying theme among many of these indications is that they involve hypoxia and/or inflammation as prime drivers of the pathology. For many of the indications the use of HBOT is based on the underlying pathophysiology, where the presence of hypoxia and/or inflammation indicates that HBOT might be useful. The outcome data, however, are based on case reports or small case series. This project will collect consistently acquired outcome data for indications where HBOT is being used, but the underlying data supporting its use is limited.

Conditions

• Post-COVID-19 Condition
• Ulcerative Colitis
• Crohn Disease
• Calciphylaxis
• Frostbite
• Acute COVID-19
• Pyoderma Gangrenosum
• Pterygium
• Hypospadias
• Head Trauma
• Pneumatosis Intestinalis
• Ischemic Bowel
• Raynaud Syndrome
• Malignant Otitis Externa
• Nonarteritic Anterior Ischemic Optic Neuropathy
• Central Retinal Vein Occlusion
• Femoral Head Necrosis
• Invasive Fungal Infection
• Chronic Anal Fissure
• Vasculitic Ulcer
• Graft-vs-Host Disease
• Decubitus Ulcer
• Greater Trochanteric Pain Syndrome
• Rectovaginal Fistula
• Pouchitis
• Tinnitus
• Clostridium Enterocolitis
• Branch Retinal Artery Occlusion
• Axonotmesis
• Multiple Sclerosis
• Inclusion Body Myositis
• Epidermolysis Bullosa (EB)
• Osteonecrosis
• Ulcer Ischemic
• Avascular Necrosis of Bone
• Prosthesis Related Infections
• Facial Filler Injections
• Cystitis Chronic
• Ligament Injury
• Anastomosis, Leaking
• Cartilage Injury

Interventions

Type	Name	Description
DEVICE	Hyperbaric oxygen treatment (HBOT)	Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.
DRUG	100% Oxygen	Receiving 100% oxygen as part of HBOT

Timeline

• Start date: 2026-03-01
• Primary completion: 2035-12-01
• Completion: 2035-12-01
• First posted: 2025-11-21
• Last updated: 2026-01-07

Regulatory

• FDA-regulated drug study
• FDA-regulated device study