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
- 64
- 试验地点
- 2
- 主要终点
- 1 Change in blood parameters to identify potent biomarker for the development of varicose veins.
研究概览
简要总结
This is a 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 self-declared knee pain. A maximum of 64 panelists aged 35 to 70 years will be enrolled to get 60 evaluable panelists (30 per group).
- 32 panelists with diagnosed varicose veins with self-reported knee pain will be enrolled.
- 32 healthy panelists will be enrolled as a control group.
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.
Visit 01 (Day 01) :Screening, enrolment, evaluations at baseline, test product and diary distribution, followed by evaluations after 1 hour (+10 minutes).
Visit 02 (Day 03 (+1 day) : Evaluations at Day 03 (+1 day).
Visit 03 (Day 07(±2 days)): 1-week evaluations at Day 07 (±2 days).
Visit 04 (Day 28(±2 days)): Subject diary review, followed by end of study evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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 (by surgeon) (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.
结局指标
主要结局
1 Change in blood parameters to identify potent biomarker for the development of varicose veins.
时间窗: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. | All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28.
2 Change in blood circulation, blood valve function, vessel anatomy in saphenofemoral junction (SFJ), great saphenous vein (GSV) and small saphenous vein (SSV) using duplex ultrasound of the affected leg.
时间窗: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. | All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28.
3 Change in overall health of knee joints based on questionnaire.
时间窗: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. | All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28.
4 Change in VAS pain score.
时间窗: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. | All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28.
5 Change in CEAP classification of the severity of varicose veins.
时间窗: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. | All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28.
次要结局
- 1 Change in blood pressure of upper and lower leg (standing or sitting)(2 Change in ankle-brachial index)
研究者
Dr Himesh Chauhan
Ananta Multispeciality Hospital