Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with Varicose Vein and Self-Declared Knee Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in Blood Parameters (MCP-1)
研究概览
简要总结
Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain.
Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled.
详细描述
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.
Panelists shall be instructed to visit the facility for the following scheduled visits:
Visit 01 (Day 01): Screening, enrolment, evaluations at baseline, test product and *subject diary distribution, followed by evaluations after 1 hour (+10 minutes).
Visit 02 (Day 03 +1 day): Evaluations at Day 03 (+1 day).
Visit 03 (07 ±2 days): 1-week evaluations at Day 07 (±2 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
- •Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
- •Panelist of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, vasectomy or abstinence).
- •32 panelists with clinical diagnosis of varicose veins in any of the leg with C2 class as per CEAP classification (Appendix II), with self-declared knee pain.
- •32 healthy panelists will be enrolled.
- •Documented written informed consent from the panelists.
- •Panelists having willingness and ability to adhere to study directions, and agreeing not to use any other or wear any other similar product at the same designated site for this study and returning for all specified visits for follow-up.
- •Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment.
排除标准
- •Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the panelists unfit to take part in the study.
- •Any recent surgery which may hinder in the study specific assessments and overall outcome.
- •Panelists with class C3 to C6 of CEAP classification.
- •Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
- •Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
- •Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
- •Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
- •Panelists who are not willing to adhere to the study protocol.
研究组 & 干预措施
Varicose Vein Group
Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours.
干预措施: Bio-Ray Knee Guard (Device)
Healthy Group
Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours.
干预措施: Bio-Ray Knee Guard (Device)
结局指标
主要结局
Change in Blood Parameters (MCP-1)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker MCP-1.
Change in Blood Parameters (D-dimer)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker D-dimer.
Change in Blood Parameters (Rheumatoid factor)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker rheumatoid factor.
Change in Blood Parameters (IL-6)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker IL-6.
Change in Blood Parameters (C-reactive protein)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker C-reactive protein.
Change in Blood Parameters (anti-CCP antibodies)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker anti-CCP antibodies.
Change in Blood Parameters (TNF-α)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker TNF-α.
Change in Blood Circulation (SFJ)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of saphenofemoral junction by duplex ultrasound.
Change in Blood Circulation (GSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of great saphenous vein by duplex ultrasound.
Change in blood valve function (SSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of small saphenous vein by duplex ultrasound.
Change in VAS pain score (only for vericose vain panelist)
时间窗: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess the effectiveness of the test product in terms of change in VAS pain score of Knee. Where 0= No pain 10 = worst pain
Change in Blood Circulation (SSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of small saphenous veins by duplex ultrasound.
Change in blood valve function (SFJ)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of saphenofemoral junction by duplex ultrasound.
Change in vessel anatomy (SFJ)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of saphenofemoral junction by duplex ultrasound.
Change in vessel anatomy (SSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of small saphenous vein by duplex ultrasound.
Change in overall health of knee joint.
时间窗: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess the effectiveness of the test product in terms of change in overall health of knee joint based on questionnaire.
Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology)
时间窗: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess effectiveness of the test product in terms of change in CEAP classification of the severity of varicose vein. C0 = No visible or palpable signs of venous disease, C1= Telangiectasias or reticular veins C2 = Varicose vein and
Change in blood valve function (GSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of great saphenous vein by duplex ultrasound.
Change in vessel anatomy (GSV)
时间窗: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of great saphenous vein by duplex ultrasound.
次要结局
- Change in blood pressure(On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.)
- Change in ankle-brachial index(On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.)
- Change in body leg temperature(On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.)
- Overall improvement in symptoms and satisfaction with the use of test product(On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.)
研究者
Dr Nayan Patel
Sub-Investigator
NovoBliss Research Pvt Ltd