Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain
研究概览
简要总结
Special metals (e.g. Germanium, Titanium, and π element) can be used to produce far-infrared radiation. The applications of these metals in promoting blood circulation are worth investigating. This clinical trial recruited subjects for using tape made up of Ge, Ti, and π element developed by Green Energy Nano Technology Co., Ltd. We assumed that the experimental tape can improve the participants' peripheral blood circulation and their quality of life. In this clinical trial, the clinical efficacy and safety of the test products were assessed using physical examination and questionnaires.
详细描述
This study is made of two open-labeled, two-arm studies. 20 to 80 years old patient diagnosed with varicose veins were included in the study. Besides, patient with the following characteristics was excluded: vulnerable group, patient with an open wound at lower limb which cannot be taped, unable to express willingness clearly, Dyslexia, and inability to ambulate.
The final number of total participant is 86 participants and 66 out of 86 participants were assigned to the first study which is divided into 2 groups, the experimental and control group. The experimental group received the experimental tape as treatment, and the control group didn't receive any treatment. The participants will fill in the questionnaires including visual Analogue Scale and quality of life on the first day of the study, and fill the same questionnaires seven days later.
Furthermore, the rest of the 20 participants were assigned to the second study. The researchers evaluate their peripheral blood circulation by Segmental Blood Pressure over Pulse Volume Recording (SBP/PVR), Maximum Venous Outflow over Segmental Venous Capacitance (MVO/SVC), and Ankle Brachial Index (ABI) before they received the treatment, then the researchers inspect the same indexes after they received the treatment right after the first tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiovascular disease (deep Vein Thrombosis or Chronic venous insufficiency)
排除标准
- •Vulnerable populations
- •wound at lower limb which can not take the intervention
- •one can not make express consent clearly
- •who need physical assistance during ambulation
- •nonfunctional ambulator
研究组 & 干预措施
treatment group
the data is collected from the same participant after the intervention.
干预措施: tape (Device)
Control group
The Collect the data from the same participant before the intervention as control
结局指标
主要结局
Visual Analog Scale (VAS) Pain
时间窗: 1 day
VAS is measurement instrument for describing pain severity or intensity. The pain scale is range from 0 to 10, representing "no hurt" to "hurt worst", respectively.
Ankle-Brachial Pressure Index
时间窗: 1 day
Detect the pressure difference in percentage between brachial pressure and ankle pressure by the pulse volume record and ultrasound device.
MVO/SVC
时间窗: 1 day
The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)
次要结局
- Kidney Disease Quality of Life(Day 0 (before intervention) and Day 7 (after using the intervention for 7 days))
研究者
Juin-Hong Cherng
Assistant Professor
National Defense Medical Center, Taiwan