Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines

Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines: a Pilot Study

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02563678

Acronym

O2B

Enrollment

Registered

2015-09-30

Start date

2015-04-30

Completion date

2023-12-31

Last updated

2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Brief summary

In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.

Detailed description

The investigators are interested in studying the influence of hyperbaric oxygen on neutrophils (a kind of white blood cell) and cytokines (cell proteins). Hyperbaric oxygen can enhance the way the immune system works, but the investigators don't fully know how that happens. the investigators are doing this study to learn more about this question.

Interventions

DRUGHyperbaric Oxygen

Hyperbaric oxygen therapy

OTHERHyperbaric Air/Oxygen

Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber

OTHERNormobaric oxygen

Breathing 100% oxygen at normal, atmospheric pressure

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Cohort 1: Diabetic hyperbaric patients with active, chronic infection Inclusion Criteria: * Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis) * Diabetes mellitus * Current antibiotic use for active infection

Exclusion criteria

* Prior treatment with hyperbaric oxygen within the last 30 days * Consistent vitamin C or vitamin E supplementation in the past year * Active tobacco use * Pregnancy Cohort 2: Hyperbaric patients without diabetes or active infection Inclusion Criteria: \- Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis)

Design outcomes

Primary

Measure	Time frame
Oxidative Burst Assay	Within 30 minutes after chamber session 1

Countries

United States

Contacts

Primary ContactLindell K Weaver, MD

lindell.weaver@imail.org801-408-3623

Backup ContactSusan Churchill, APRN-NP

susan.churchill@imail.org801-408-3623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026