2024-511743-26-00已完成4 期
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 6
- 主要终点
- Major amputation rate after 12-months of follow-up
研究概览
简要总结
The aim of the study is to confirm or refute the hypothesis that HBOT is effective as an adjunctive treatment to standard wound care for patients with an ischemic DFU to prevent major amputations and to establish the optimal number of sessions to obtain this purported effect.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Type I or II diabetes
- •One or more deep and clinically infected lower extremity ulcers, classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
- •Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
- •Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
- •Patients have to be discussed in, and included after a multidisciplinary consultation.
- •Written informed consent
排除标准
- •Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- •Insufficient proficiency of local language/English, or inability to complete the questionnaires
- •Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
- •End-stage renal disease requiring dialysis
- •Metastasized malignancy
- •Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
- •Recent thoracic surgery or middle ear surgery
- •Severe epilepsy
- •Uncontrollable high fever
结局指标
主要结局
Major amputation rate after 12-months of follow-up
Major amputation rate after 12-months of follow-up
次要结局
未报告次要终点
研究者
Principal Investigator
Scientific
Amsterdam UMC Stichting
研究点 (6)
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