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

NCT ID: NCT04025619

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-06-20

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

the data is collected from the same participant after the intervention.

Group Type: EXPERIMENTAL

tape

Intervention Type: DEVICE

Sports tape

Control group

The Collect the data from the same participant before the intervention as control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tape

Sports tape

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Juin-Hong Cherng

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Defense of Medical Center, Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

GreenE2017

Identifier Type: -

Identifier Source: org_study_id