NCT06693180招募中不适用
Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Major amputation rate
研究概览
简要总结
Overview of available data to assess the benefits of HBOT to DFU patients
详细描述
10 year retrospective registry to measure outcomes regarding major amputations, mortality, hospital admissions in patients with a diabetic foot ulcer with peripheral ischaemia. Two groups will be compared: complementary HBOT and a control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus
- •Meggitt-Wagner classification grade 2-4, existing > 4 weeks
- •Complete 1 year follow-up
排除标准
- •Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- •Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within the last 3 months
- •Metastasized malignancy
- •Left ventricular ejection fraction (EF) <20% or external pacemaker
- •Recent thoracic or middle ear surgery
- •Severe epilepsy
- •Uncontrollable high fever
- •Pregnancy
结局指标
主要结局
Major amputation rate
时间窗: 1 year
Major (above the ankle) amputation rate
次要结局
- Mortality(1 year)
- Amputation-free survival rate(1 year)
- Complete wound healing(1 year)
- Pain score(1 year)
- Additional vascular interventions(1 year)
研究者
Dirk T. Ubbink
Prof.
University of Amsterdam
研究点 (1)
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