Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Device: tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiovascular disease (deep Vein Thrombosis or Chronic venous insufficiency) Exclusion Criteria: Vulnerable populations wound at lower limb which can not take the intervention one can not make express consent clearly dyslexia who need physical assistance during ambulation nonfunctional ambulator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups of participant, one of the group took the questionnaire then received the intervention for seven days, then took the same questionnaire again. The other group took the physical examination and received the intervention immediately, then took the physical examination again when the intervention is on the treating area.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>the data is collected from the same participant after the intervention. | Device: tape<br>* Sports tape<br>|
| No Intervention: Control group<br>The Collect the data from the same participant before the intervention as control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-Brachial Pressure Index | Detect the pressure difference in percentage between brachial pressure and ankle pressure by the pulse volume record and ultrasound device. | 1 day | 
| MVO/SVC | The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC) | 1 day | 
| Visual Analog Scale (VAS) Pain | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Disease Quality of Life | Questionnaire to assess generic and kidney-disease targeted aspects of quality of life | Day 0 (before intervention) and Day 7 (after using the intervention for 7 days) |