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出境医 / 临床实验 / Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Device: tape Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : June 20, 2019
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Taiwan
National Defense of Medical Center, Tri-Service General Hospital
Taipei city, Taiwan, 114
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE March 12, 2018
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • 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.
  • MVO/SVC [ Time Frame: 1 day ]
    The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • 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.
  • MVO/SVC [ Time Frame: 1 day ]
    The ratio of maximum venous outflow to the segmental venous capacitance
  • VAS Pain [ Time Frame: 1 day ]
    Visual Analog Scale for Pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
Official Title  ICMJE Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Device: tape
Sports tape
Study Arms  ICMJE
  • Experimental: treatment group
    the data is collected from the same participant after the intervention.
    Intervention: Device: tape
  • No Intervention: Control group
    The Collect the data from the same participant before the intervention as control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2019) 		86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 20, 2019
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025619
Other Study ID Numbers  ICMJE GreenE2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juin-Hong Cherng, National Defense Medical Center, Taiwan
Study Sponsor  ICMJE National Defense Medical Center, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Defense Medical Center, Taiwan
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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