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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Device: tape

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan, 114
    • National Defense of Medical Center, Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: GreenE2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No