Post-COVID-19 ConditionPhase 4NCT07240649
Emerging Indications for Hyperbaric Oxygen Treatment
A Phase 4 study testing Hyperbaric oxygen treatment (HBOT) and 100% Oxygen in people with Post-COVID-19 Condition and Ulcerative Colitis, run by Jay C. Buckey Jr..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Hyperbaric oxygen treatment (HBOT) and 100% Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients referred for HBOT with an emerging indication
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jay Buckey contact
About this study
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.
Read the 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
- Being tested
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Calciphylaxis, Frostbite, Pyoderma Gangrenosum, Pterygium, Hypospadias, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen treatment (HBOT)Device
Also called HBO2
Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.
100% OxygenDrug
Also called O2
Receiving 100% oxygen as part of HBOT
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen treated group | Experimental | 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. Receives: Device: Hyperbaric oxygen treatment (HBOT); Drug: 100% Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life EuroQOL EQ-5D-5L Questionnaire
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.
Measured: Within one week of starting HBO2 and within one week of ending HBO2 treatment
Secondary outcomes (11)
Urogenital Distress Inventory
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Bowel symptoms questionnaire
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Head and Neck Questionnaire
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Perianal Crohn's Symptom Index Questionnaire
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Wound Score (Strauss Score)
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Subjective Assessment
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.
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Calciphylaxis Measurement Package
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
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Frostbite Measurement Package
For all individuals treated for frostbite data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventions
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Pyoderma Gangrenosum Measurement Package
For all individuals treated for pyoderma gangrenous data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventions
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Raynaud Syndrome Measurement Package
For all individuals treated for Raynaud's data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventions
Measured: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2026 (estimated)
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jay C. Buckey Jr.
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Sponsor-investigator, Jay C. Buckey Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Jay Buckey, Principal investigator, Dartmouth-Hichcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240649
- Sponsor's protocol ID
- STUDY02003096
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Tanaka HL, Rees JR, Zhang Z, Ptak JA, Hannigan PM, Silverman EM, Peacock JL, Buckey JC; Multicenter Registry for Hyperbaric Oxygen Treatment Consortium. Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study. Interact J Med Res. 2024 Aug 20;13:e53821. doi: 10.2196/53821.
PubMed 39078624Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Moses RA, Kertis JA, Hannigan PM, Juggan SA, Peacock J, Bennett M, Buckey JC. International Multicenter Registry for Hyperbaric Oxygen Therapy: Results through June 2021. Undersea Hyperb Med. 2022 Third Quarter;49(3):275-287.
PubMed 36001560Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Kertis JA, Hannigan PM, Peacock JL, Buckey JC. Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis. JMIR Res Protoc. 2020 Aug 17;9(8):e18857. doi: 10.2196/18857.
PubMed 325795371. Huang ET. Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023 2023. 445 p.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emerging Indications for Hyperbaric Oxygen Treatment
- ClinicalTrials.gov ID
- NCT07240649
- Acronym / sponsor ID
- STUDY02003096
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis, Frostbite, Acute COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jay C. Buckey Jr.University, hospital or other
- Collaborators
- Dartmouth College
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen treated group | Experimental | Device: Hyperbaric oxygen treatment (HBOT), Drug: 100% OxygenThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for HBOT with an emerging indication
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen treatment (HBOT)Also: HBO2Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber. | Device | Hyperbaric oxygen treated group |
| 100% OxygenAlso: O2Receiving 100% oxygen as part of HBOT | Drug | Hyperbaric oxygen treated group |
Primary outcome
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.
11 secondary outcomes
Urogenital Distress Inventory
Time frame: 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
Head and Neck Questionnaire
Time frame: 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
Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire
Time frame: 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
Subjective Assessment
Time frame: 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
Frostbite Measurement Package
Time frame: 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
Raynaud Syndrome Measurement Package
Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 39078624Tanaka HL, Rees JR, Zhang Z, Ptak JA, Hannigan PM, Silverman EM, Peacock JL, Buckey JC; Multicenter Registry for Hyperbaric Oxygen Treatment Consortium. Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study. Interact J Med Res. 2024 Aug 20;13:e53821. doi: 10.2196/53821.
- Background: PubMed 36001560Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Moses RA, Kertis JA, Hannigan PM, Juggan SA, Peacock J, Bennett M, Buckey JC. International Multicenter Registry for Hyperbaric Oxygen Therapy: Results through June 2021. Undersea Hyperb Med. 2022 Third Quarter;49(3):275-287.
- Background: PubMed 32579537Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Kertis JA, Hannigan PM, Peacock JL, Buckey JC. Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis. JMIR Res Protoc. 2020 Aug 17;9(8):e18857. doi: 10.2196/18857.
- Background1. Huang ET. Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023 2023. 445 p.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Buckey contact
Jay Buckey principal investigator
Dartmouth-Hichcock Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric oxygen treatment (HBOT) and 100% Oxygen in people with Post-COVID-19 Condition and Ulcerative Colitis, run by Jay C. Buckey Jr..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Leigh (540-819-5715, samantha.m.leigh@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life EuroQOL EQ-5D-5L Questionnaire (time frame: Within one week of starting HBO2 and within one week of ending HBO2 treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240649, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.