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Completed

NCT Number: NCT04025619

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Defense of Medical Center, Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tape

Device

Sports tape

Primary outcomes

  1. Ankle-Brachial Pressure Index

    Time frame: 1 day

    Detect the pressure difference in percentage between brachial pressure and ankle pressure by the pulse volume record and ultrasound device.

  2. MVO/SVC

    Time frame: 1 day

    The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)

  3. Visual Analog Scale (VAS) Pain

    Time frame: 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.

Secondary outcomes

  1. Kidney Disease Quality of Life

    Time frame: Day 0 (before intervention) and Day 7 (after using the intervention for 7 days)

    Questionnaire to assess generic and kidney-disease targeted aspects of quality of life

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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