Changes in the wound microbiome and their impact on chronic wound healing under hyperbaric conditions
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
To evaluate the impact of Hyperbaric Oxygen Therapy (HBOT) on the diversity and composition of the wound microbiome in chronic wound patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of a chronic wound (e.g., diabetic ulcer, vascular ulcer, or pressure ulcer) persisting for over one month despite standard wound care.
- •Willingness and ability to undergo a minimum of 30 HBOT sessions over 6 weeks.
- •Suitability for HBOT, determined by meeting standard HBO suitability criteria.
- •Provision of informed consent to participate in the study
排除标准
- •Concurrent participation in another clinical trial affecting wound healing or microbiome.
- •Acute wounds or wounds from infectious diseases outside the specified inclusion (e.g., osteomyelitis).
- •Contraindications to HBOT (e.g., untreated pneumothorax, severe claustrophobia).
- •Conditions impairing immune function (e.g., active HIV/AIDS, current chemotherapy).
- •Pregnancy or breastfeeding.
- •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
结局指标
主要结局
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).
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
microbial diversity and composition within the wound microbiome will be assessed longitudinally before, during, and after the HBOT treatment period
次要结局
- • 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.
研究者
KKS
Scientific
Medical University Of Graz