Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Peripheral arterial tonometry (PAT)
研究概览
简要总结
The purpose of this clinical study is to test whether or not patients treated with HBOT for diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index (RHI) measured by the peripheral arterial tonometry (PAT).
详细描述
Measurement and monitoring of endothelial function can be used for prediction of outcome in acute, severe disease. Diabetic patients have a poorer peripheral vascular function measured by peripheral arterial tonometry (PAT) as compared to normals, but the effect of hyperbaric oxygen therapy (HBOT) on endothelial function in these patients is unknown. Measurement of PAT in patients with diabetic foot ulcers undergoing HBOT, may help to improve treatment and changes in the reactive hyperemic index (RHI) might correlate with wound healing in these patients.
Peripheral arterial tonometer (PAT) has been shown to be an easy, fast and standardized method for measuring the peripheral arterial endothelial function. The method is also operator-independent and has a high reproducibility.
The PAT apparatus (ENDOPAT) measures the post-ischemic response to a five-minute blood flow occlusion of the upper arm, and the relationship between the pre-and post-ischemic pulse amplitude is expressed as a reactive hyperemic index (RHI). The normal RHI in young healthy persons is more than 2, while in critically ill patients and patients with diabetes, hypertension or heart disease it is significantly decreased.
The study aims to test whether or not patients treated with HBOT for diabetic foot ulcers will demonstrate an improvement of the endothelial function in the peripheral vessels, i.e. an increase in RHI measured by the PAT. Similarly, essential mediators of angiogenesis and nitric oxide bioavailability will be measured in peripheral blood taken during the PAT measurements which will be performed at the time of inclusion, before HBOT and subsequently for each 10th HBOT session.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diabetic patients with foot ulcer
- •None diabetic patients
- •Age > 18 years
- •Patients referred to hyperbaric oxygen therapy.
- •Patients who have given written informed consent to participate in the study
排除标准
- •Patients who cannot cooperate to participate in the study
- •Patients who do not understand or speak Danish or English
- •Allergy to the materials used in the experiment.
- •Patients < 18 years
结局指标
主要结局
Peripheral arterial tonometry (PAT)
时间窗: 18 weeks
Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.
次要结局
- Nitric oxide and cytokine expression(18 weeks)
研究者
Ole Hyldegaard
Associate Professor, Medical Director, MD, Ph.D, DMSci
Rigshospitalet, Denmark
