A Phase 4 interventional study of Hyperbaric oxygen treatment (HBOT) and 100% Oxygen in Post-COVID-19 Condition, Ulcerative Colitis and Crohn Disease, sponsored by Jay C. Buckey Jr.. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Jay C. Buckey Jr. · Phase 4, Interventional, and 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.
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →This is the only study on the registry with Jay C. Buckey Jr. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Drug: 100% Oxygen
Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.
Also known as: HBO2
Receiving 100% oxygen as part of HBOT
Also known as: O2
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.
Time frame: Within one week of starting HBO2 and within one week of ending HBO2 treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Dec 2035, 109 months later.
Of 48 non-industry phase 4 interventional studies under Colitis, Ulcerative, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 66. This study's planned 109 months is above that.
Counting every sponsor, half of 63 studies reached it within 43 months; a quarter within 25 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxygen