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Study of the effect of hyperbaric oxygen therapy on the bacteria in chronic wounds

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with chronic wounds, which are sores that do not heal within the expected timeframe. The research aims to evaluate the impact of hyperbaric oxygen therapy, a method where a person breathes oxygen through a specialized breathing tube while inside a pressurized chamber, on the types of bacteria living in these wounds. These bacteria are part of the wound microbiome, which refers to the collection of tiny living organisms that inhabit the area around and inside the wound.

Participants will undergo a period of treatment lasting six weeks. During this time, the effects of the pressurized oxygen on the wound's environment and the healing process will be observed. The study will look at how the different types of microorganisms in the wound change and how this influences the body's ability to repair the tissue and reduce the size of the sore.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of therapy

    The hyperbaric oxygen therapy period begins. this involves breathing medical oxygen through a specialized breathing method.

  2. Step 2

    Treatment period

    The oxygen therapy is administered for a duration of 6 weeks.

    The medical oxygen is inhaled for 135 minutes during each session.

  3. Step 3

    Monitoring and assessments

    The microbiome, which refers to the collection of tiny organisms living in or on the wound, is monitored before, during, and after the treatment.

    The wound size, presence of infection, and tissue regeneration are assessed to track healing.

    Levels of pain or discomfort related to the wound are recorded.

  4. Step 4

    Completion of intervention

    At week 6, the hyperbaric oxygen therapy period concludes.

    A final evaluation of the microbial diversity within the wound is performed at this time.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older.
  • You must have a chronic wound, which is a sore or injury that has not healed after more than one month of regular medical treatment. Examples include diabetic ulcers (sores caused by diabetes), vascular ulcers (sores caused by issues with blood flow), or pressure ulcers (sores caused by prolonged pressure on the skin).
  • You must be willing and able to complete at least 30 sessions of Hyperbaric Oxygen Therapy (HBOT), which is a treatment where you breathe pure oxygen in a pressurized chamber, over a period of 6 weeks.
  • You must be healthy enough to undergo Hyperbaric Oxygen Therapy (HBOT) based on standard medical safety checks.
  • You must provide informed consent, which means you agree to take part in the study after understanding all the details and risks.

Who cannot join the trial?

6 criteria

  • You are currently taking part in another clinical trial (a research study involving people) that affects how wounds heal or the microbiome (the collection of tiny organisms like bacteria living on the body).
  • You have acute wounds (new or sudden injuries) or wounds caused by infectious diseases, such as osteomyelitis (an infection in the bone), that were not specifically allowed for this study.
  • You have medical reasons why you cannot receive Hyperbaric Oxygen Therapy (a treatment where you breathe pure oxygen in a pressurized chamber), such as an untreated pneumothorax (a collapsed lung) or severe claustrophobia (an extreme fear of being in small, enclosed spaces).
  • You have conditions that affect your immune function (your body's ability to fight off germs), such as an active case of HIV/AIDS or if you are currently receiving chemotherapy (medicine used to treat cancer).
  • You are currently pregnant or breastfeeding.
  • You are currently using the medication disulfiram (brand name Antabuse®), because it may interfere with how your body handles oxygen and could increase the risk of oxygen toxicity (harm caused to the body by breathing too much oxygen).
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Investigated drugs

Oxygen therapy is used in this study to see how breathing in compressed medical oxygen in a pressurized chamber can help change the types of bacteria living in a chronic wound and help the wound heal better.

What is already known about the treatment

Oxygen - This medication is a medicinal gas that is inhaled through a breathing device to increase the amount of oxygen in the body. It is widely used in medical practice to treat patients who are not getting enough oxygen into their blood or tissues. In this specific setting, it is used to help heal long-term wounds by providing higher levels of oxygen to the affected area. On a molecular level, it works by making more oxygen available to cells, which helps them repair tissue and fight off harmful bacteria.

Investigated diseases

Chronic wounds - These are sores or injuries that fail to heal through the normal biological process within a typical timeframe. They often result from ongoing inflammation or issues with blood flow and tissue repair. As the condition progresses, the skin and underlying tissues may experience persistent damage. This delay in healing can allow various microorganisms to settle in the area. The presence of these microbes can further alter the natural healing environment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523863-39-00Estimated enrolment80 patientsSponsorMedical University Of Graz

sourced from the EU Clinical Trials Register and site verification

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