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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025619
• Other study ID #: GreenE2017
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: September 2020
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Device:
• tape
Sports tape

Locations

Country	Name	City	State
Taiwan	National Defense of Medical Center, Tri-Service General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	MVO/SVC	The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)	1 day
Primary	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	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)