Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
研究概览
简要总结
The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diabetes mellitus type 2
- •ulcus cruris (plantar)
- •min. 6 weeks of standard wound therapy without success
- •intact big toe on wound side
排除标准
- •participation in a clinical trial in the last 5 weeks
- •confounding medical treatment, e.g. prostaglandin
- •vascular diseases other than peripheral arterial occlusive disease
- •diseases which may affect the autonomous nervous system or wound healing, except diabetic concomitant diseases (e.g., polyneuropathy, angiopathy)
- •drug abuse
- •active implanted devices
- •pregnancy or nursing
研究组 & 干预措施
auricular vagal nerve stimulation
Study participants (healthy and diabetics) are treated with auricular vagal nerve stimulation using four needle electrodes connected to an electrical stimulation device (PrimeStim). After an acclimatization phase the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and another 10 minutes paused stimulation. This intervention is repeated on four consecutive days. Needle electrodes stay fixed over the whole study period.
Two different stimulation schemes are tested, each being assessed twice in random order. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle.
During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature.
干预措施: PrimeStim (Device)
结局指标
主要结局
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
时间窗: within 4 days of intervention
Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (30 seconds overlap). Changes in mean value and standard deviation of heart rate variability between healthy and diabetic patients will be assessed using statistical tests.
change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
时间窗: within 4 days of intervention
Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion. Changes in mean value and standard deviation of local blood perfusion index between healthy and diabetic patients will be assessed using statistical tests.
次要结局
- Changes in oxygen saturation of the toe and wound(within 4 days of intervention)
- Tolerance of stimulation(within 4 days of intervention)
- Perception of Stimulation(within 4 days of intervention)
- Change in HRV and local BPI due to distinct stimulation patterns(within 4 days of intervention)
- Changes in respiratory activity(within 4 days of intervention)
- Changes in partial transcutaneous oxygen pressure of the wound region(within 4 days of intervention)
- Changes in blood pressure(within 4 days of intervention)
- Change of local BPI in upper and lower extremities(within 4 days of intervention)
- Changes in foot skin temperature(within 4 days of intervention)
- Changes of C reactive protein- and leukocyte-concentration in serum(within 4 days of intervention)
- Adverse effects of stimulation(within 4 days of intervention)
研究者
Dr. Jozsef Constantin Széles
Dr.med.
Medical University of Vienna