Changes in the wound microbiome and their impact on chronic wound healing under hyperbaric conditions

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Phenomena and Processes [G] - Microbiological Phenomena [G06], Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Immune System Diseases [C20]

Trial duration

5 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the impact of Hyperbaric Oxygen Therapy (HBOT) on the diversity and composition of the wound microbiome in chronic wound patients

Secondary objectives 4

1. • To correlate HBOT-induced microbiome alterations with wound healing markers, such as wound closure rate, infection incidence, and tissue regeneration quality.
2. • Establishment of a Long-Term Biobank and Microbiome Dataset for Chronic Wounds
3. • To assess patient-reported outcomes and quality of life measures related to microbiome changes during HBOT.
4. • To conduct a cost-effectiveness analysis of HBOT for chronic wound treatment.

Conditions and MedDRA coding

chronic wounds

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. • Age 18 years or older
2. • Diagnosis of a chronic wound (e.g., diabetic ulcer, vascular ulcer, or pressure ulcer) persisting for over one month despite standard wound care.
3. • Willingness and ability to undergo a minimum of 30 HBOT sessions over 6 weeks.
4. • Suitability for HBOT, determined by meeting standard HBO suitability criteria.
5. • Provision of informed consent to participate in the study

Exclusion criteria 6

1. • Concurrent participation in another clinical trial affecting wound healing or microbiome.
2. • Acute wounds or wounds from infectious diseases outside the specified inclusion (e.g., osteomyelitis).
3. • Contraindications to HBOT (e.g., untreated pneumothorax, severe claustrophobia).
4. • Conditions impairing immune function (e.g., active HIV/AIDS, current chemotherapy).
5. • Pregnancy or breastfeeding.
6. • Current use of disulfiram (Antabuse®), due to its potential inhibition of superoxide dismutase and the resulting, as yet unquantified, theoretical increased risk of oxygen toxicity during HBOT

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary endpoint will be the between-group difference in wound microbiome alpha-diversity at the prespecified primary evaluation time point Week 6 (end of the 6-week HBOT intervention period), quantified by the Shannon diversity index (confirmatory primary endpoint).
2. microbial diversity and composition within the wound microbiome will be assessed longitudinally before, during, and after the HBOT treatment period

Secondary endpoints 4

1. • Clinical wound healing indicators (e.g., wound size reduction, infection rates, tissue regeneration quality).
2. • A structured biobank of microbiome samples and metadata from chronic wounds to enable future research on wound healing, resistance mechanisms, and HBOT-related microbial responses.
3. • Patient-reported outcomes on quality of life and wound-related pain or discomfort.
4. • Cost-effectiveness assessment of HBOT relative to conventional wound care.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

KKS

Public contact point

Organisation

Medical University Of Graz

Contact name

KKS

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications