OXYGEN for Chronic wounds|Diabetic ulcer|Vascular ulcer|Pressure ulcer

Inclusion criteria

• {"criterion_text":"- •\tAge 18 years or older\n- •\tDiagnosis of a chronic wound (e.g., diabetic ulcer, vascular ulcer, or pressure ulcer) persisting for over one month despite standard wound care.\n- •\tWillingness and ability to undergo a minimum of 30 HBOT sessions over 6 weeks.\n- •\tSuitability for HBOT, determined by meeting standard HBO suitability criteria.\n- •\tProvision of informed consent to participate in the study"}

Exclusion criteria

• {"criterion_text":"- •\tConcurrent participation in another clinical trial affecting wound healing or microbiome.\n- •\tAcute wounds or wounds from infectious diseases outside the specified inclusion (e.g., osteomyelitis).\n- •\tContraindications to HBOT (e.g., untreated pneumothorax, severe claustrophobia).\n- •\tConditions impairing immune function (e.g., active HIV/AIDS, current chemotherapy).\n- •\tPregnancy or breastfeeding.\n- •\tCurrent 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"}

Primary endpoints

• {"endpoint_text":"- 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).\n- microbial diversity and composition within the wound microbiome will be assessed longitudinally before, during, and after the HBOT treatment period","definition_or_measurement_approach":"Between-group difference in wound microbiome alpha-diversity at Week 6 quantified by the Shannon diversity index (confirmatory primary endpoint). Longitudinal assessment of microbial diversity and composition before, during and after HBOT (timing: baseline, during treatment, Week 6, and post-treatment as specified)."}

Secondary endpoints

• {"endpoint_text":"- •\tClinical wound healing indicators (e.g., wound size reduction, infection rates, tissue regeneration quality).\n- •\tA structured biobank of microbiome samples and metadata from chronic wounds to enable future research on wound healing, resistance mechanisms, and HBOT-related microbial responses.\n- •\tPatient-reported outcomes on quality of life and wound-related pain or discomfort.\n- •\tCost-effectiveness assessment of HBOT relative to conventional wound care.","definition_or_measurement_approach":"Clinical wound healing indicators measured by wound size reduction, infection incidence, and tissue regeneration quality. Biobank: collection and storage of microbiome samples and metadata. Patient-reported outcomes: validated QoL and pain/discomfort measures as collected via patient questionnaires. Cost-effectiveness: economic analysis comparing HBOT to standard care."}

Austria

Earliest CTIS Part Ii Submission Date

12-02-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

4

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria