chronic wounds
Conditions
Brief summary
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)., microbial diversity and composition within the wound microbiome will be assessed longitudinally before, during, and after the HBOT treatment period
Detailed description
• Clinical wound healing indicators (e.g., wound size reduction, infection rates, tissue regeneration quality)., • 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., • Patient-reported outcomes on quality of life and wound-related pain or discomfort., • Cost-effectiveness assessment of HBOT relative to conventional wound care.
Interventions
Sponsors
Medical University Of Graz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)., microbial diversity and composition within the wound microbiome will be assessed longitudinally before, during, and after the HBOT treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical wound healing indicators (e.g., wound size reduction, infection rates, tissue regeneration quality)., • 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., • Patient-reported outcomes on quality of life and wound-related pain or discomfort., • Cost-effectiveness assessment of HBOT relative to conventional wound care. | — |
Outcome results
None listed