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NCT Number: NCT07240649

Emerging Indications for Hyperbaric Oxygen Treatment

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.

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Key information

Conditions

Post-COVID-19 Condition Acute COVID-19 Anastomosis, Leaking Arterial Occlusive Diseases Autoimmune Diseases Autoimmune Diseases of the Nervous System Avascular Necrosis of Bone Axonotmesis Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Branch Retinal Artery Occlusion Calcinosis Calciphylaxis Calcium Metabolism Disorders Cardiovascular Diseases Cartilage Injury Central Retinal Vein Occlusion Chronic Anal Fissure Clostridium Enterocolitis Clostridium Infections Cold Injury Colitis Colitis, Ulcerative Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Cranial Nerve Diseases Craniocerebral Trauma Crohn Disease Cystitis Chronic Decubitus Ulcer Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Digestive System Diseases Digestive System Fistula Ear Diseases Embolism and Thrombosis Enteritis Enterocolitis Enterocolitis, Pseudomembranous Epidermolysis Bullosa Epidermolysis Bullosa (EB) Eye Diseases Facial Filler Injections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Femoral Head Necrosis Fistula Frostbite Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Graft vs Host Disease Graft-vs-Host Disease Gram-Positive Bacterial Infections Greater Trochanteric Pain Syndrome Head Trauma Hearing Disorders Hypospadias Ileal Diseases Ileitis Immune System Diseases Inclusion Body Myositis Infections Inflammatory Bowel Diseases Intestinal Diseases Intestinal Fistula Invasive Fungal Infection Invasive Fungal Infections Ischemic Bowel Ligament Injury Livedoid Vasculopathy Male Urogenital Diseases Malignant Otitis Externa Metabolic Diseases Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Mycoses Myositis Myositis, Inclusion Body Necrosis Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nonarteritic Anterior Ischemic Optic Neuropathy Nutritional and Metabolic Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Osteonecrosis Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Penile Diseases Peripheral Vascular Diseases Pneumatosis Intestinalis Postoperative Complications Pouchitis Pressure Ulcer Prosthesis Related Infections Prosthesis-Related Infections Pterygium Pyoderma Pyoderma Gangrenosum Raynaud Disease Raynaud Syndrome Rectal Diseases Rectal Fistula Rectovaginal Fistula Retinal Artery Occlusion Retinal Diseases Retinal Vein Occlusion Sensation Disorders Signs and Symptoms Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin Diseases, Vesiculobullous Skin Ulcer Skin and Connective Tissue Diseases Thrombosis Tinnitus Trauma, Nervous System Ulcer Ischemic Ulcerative Colitis Urogenital Abnormalities Urogenital Diseases Vaginal Diseases Vaginal Fistula Vascular Diseases Vasculitic Ulcer Venous Thrombosis Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for HBOT with an emerging indication

Exclusion criteria

  • Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)
  • Pregnant persons

Treatment and study plan

Hyperbaric oxygen treatment (HBOT)

Device

Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.

Other names: HBO2

100% Oxygen

Drug

Receiving 100% oxygen as part of HBOT

Other names: O2

Primary outcomes

  1. Quality of Life EuroQOL EQ-5D-5L Questionnaire

    Time frame: Within one week of starting HBO2 and within one week of ending HBO2 treatment

    Every individual has quality of life measured using the EuroQol EQ-5D-5L measure. The measure has 5 scales (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression), that each have 5 levels (none, slight, moderate, severe, unable). The scores are calculated using the procedures outlined in the EuroQOL handbook to create a final score on a 0-1 scale. There is also an overall visual analog scale that asks about perceived health on a 0-100 scale. Higher scores indicate better quality of life. Data are aggregated in the Multicenter Registry for Hyperbaric Oxygen Treatment.

Secondary outcomes

  1. Urogenital Distress Inventory

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    Patients with cystitis will complete the Urinogential Distress Inventory (UDI). The six questions ask about symptoms on a 4 point scale (No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4). The UDI scaled score is calculated by adding all scores and multiplying by 6 and then multiply by 25 for the scale score. Missing items are dealt with by using the mean from the answered items only. Higher score = higher disability.

  2. Bowel symptoms questionnaire

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    Those with conditions affecting the gastrointestinal tract will complete the bowel symptoms questionnaire. The questionnaire has nine questions that cover the areas of frequency, blood, pain, and urgency. Severity is rated on a 4 point scale from 0 to 4 with 4 being severe. Higher values indicate more symptoms.

  3. Head and Neck Questionnaire

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    The head and neck questionnaire has 37 questions selected from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 and the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire. The questionnaire covers dry mouth, pain, and difficulties with smell and taste. The scores are converted to a 0-100 scale with higher numbers indicating more symptoms.

  4. Perianal Crohn's Symptom Index Questionnaire

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    The perianal Crohn's symptom index has 13 questions that cover fistulas, fistula discharge, rectal discharge, bowel frequency, urgency, blood, and pain. The answers are converted to an overall summed score with higher levels indicating more symptoms.

  5. Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    Individuals with conditions involving the knee or hip will complete the HOOS questionnaire. The questions are divided into symptoms, stiffness, pain, function (daily living), function (sports), and quality of life. Symptoms are measured on a 5 point scale from none to extreme. The answers are computed into individual sub scales for each major area and an overall total score. Higher numbers indicate more symptoms.

  6. Wound Score (Strauss Score)

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    Individuals with wounds will have the wound (Strauss) score completed. The score covers five areas (Appearance, Size, Depth, Infection/Bioburden, and Perfusion). Each area is graded from best (2 points) to worst (0 points). Depth also has a possible 1.5 score for subcutaneous tissue involvement. Higher scores are better with healthy wounds in the 7.5 to 10 point range.

  7. Subjective Assessment

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    For all enrollees a 4 level subjective assessment will be completed. The scale ranges from 1 resolved/healed to 4 worse with higher levels indicating less improvement.

  8. Calciphylaxis Measurement Package

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    For individuals treated for calciphylaxis, data will be collected on the following parameters:

    Number of wounds Pre and post wound measurements in cm Number of surgical interventions

  9. Frostbite Measurement Package

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    For all individuals treated for frostbite data will be collected on:

    Number of wounds Wound measurements in cm Number of surgical interventions

  10. Pyoderma Gangrenosum Measurement Package

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    For all individuals treated for pyoderma gangrenous data will be collected on:

    Number of wounds Wound measurements in cm Number of surgical interventions

  11. Raynaud Syndrome Measurement Package

    Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

    For all individuals treated for Raynaud's data will be collected on:

    Number of wounds Wound measurements in cm Number of surgical interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Jay Buckey

CONTACT

[email protected]

Samantha Leigh

CONTACT

[email protected]

540-819-5715

Sponsors and collaborators

Lead sponsor

Jay C. Buckey Jr.

Other

Collaborators

  • Dartmouth College

Registry information

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Nov 21, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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