Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

May 1, 2026 updated by: Jay C. Buckey Jr.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric oxygen treated group
This individuals will be receiving hyperbaric oxygen treatment for the condition listed in the conditions section. Patients come daily for the treatment and receive hyperbaric oxygen at 2.0-2.4 atmospheres absolute for 90 minutes at the treatment pressure.
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.
Other Names:
  • HBO2
Drug: 100% Oxygen
Receiving 100% oxygen as part of HBOT
Other Names:
  • O2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within one week of starting HBO2 and within one week of ending HBO2 treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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.
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
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
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jay C. Buckey Jr.

Collaborators

Dartmouth College

Investigators

  • Principal Investigator: Jay Buckey, Dartmouth-Hichcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

October 26, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02003096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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