Clinical trial NCT04025619: Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
Official title: Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ankle-Brachial Pressure Index
timeFrame: 1 day
measure: MVO/SVC
timeFrame: 1 day
measure: Visual Analog Scale (VAS) Pain
timeFrame: 1 day
Secondary outcomes:
measure: Kidney Disease Quality of Life
timeFrame: Day 0 (before intervention) and Day 7 (after using the intervention for 7 days)
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Defense of Medical Center, Tri-Service General Hospital
Study officials:
References: