A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists with Varicose Vein and Knee Pain.

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.

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins with Self-declared Knee Pain
• Intervention / Treatment: Device: Bio-Ray Knee Guard

Detailed Description

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).

Visit 04 (28±2 days): Subject diary review, followed by end of study evaluations.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmadabad, Gujarat, India, 382481
      • NovoBliss Research Pvt.Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
2. Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
3. 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).
4. 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.
5. 32 healthy panelists will be enrolled.
6. Documented written informed consent from the panelists.
7. 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.
8. Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment.

Exclusion Criteria:

1. 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.
2. Any recent surgery which may hinder in the study specific assessments and overall outcome.
3. Panelists with class C3 to C6 of CEAP classification.
4. Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
5. Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
6. Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
7. Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
8. Panelists who are not willing to adhere to the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Bio-Ray Knee Guard; Wear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours)
Other: 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.	Device: Bio-Ray Knee Guard; Wear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Parameters (D-dimer)	To assess the effectiveness of the test product in terms of determining the biomarker D-dimer.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (C-reactive protein)	To assess the effectiveness of the test product in terms of determining the biomarker C-reactive protein.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (Rheumatoid factor)	To assess the effectiveness of the test product in terms of determining the biomarker rheumatoid factor.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (anti-CCP antibodies)	To assess the effectiveness of the test product in terms of determining the biomarker anti-CCP antibodies.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (MCP-1)	To assess the effectiveness of the test product in terms of determining the biomarker MCP-1.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (IL-6)	To assess the effectiveness of the test product in terms of determining the biomarker IL-6.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (TNF-α)	To assess the effectiveness of the test product in terms of determining the biomarker TNF-α.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (SFJ)	To assess the effectiveness of the test product in terms of change in blood circulation of saphenofemoral junction by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (GSV)	To assess the effectiveness of the test product in terms of change in blood circulation of great saphenous vein by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (SSV)	To assess the effectiveness of the test product in terms of change in blood circulation of small saphenous veins by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (SFJ)	To assess the effectiveness of the test product in terms of change in blood valve function of saphenofemoral junction by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (GSV)	To assess the effectiveness of the test product in terms of change in blood valve function of great saphenous vein by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (SSV)	To assess the effectiveness of the test product in terms of change in blood valve function of small saphenous vein by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (SFJ)	To assess the effectiveness of the test product in terms of change in vessel anatomy of saphenofemoral junction by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (GSV)	To assess the effectiveness of the test product in terms of change in vessel anatomy of great saphenous vein by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (SSV)	To assess the effectiveness of the test product in terms of change in vessel anatomy of small saphenous vein by duplex ultrasound.	On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in overall health of knee joint.	To assess the effectiveness of the test product in terms of change in overall health of knee joint based on questionnaire.	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.
Change in VAS pain score (only for vericose vain panelist)	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	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.
Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology)	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	To assess the effectiveness of the test product in terms of change in blood pressure of upper leg (standing or sitting).	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 blood pressure	To assess the effectiveness of the test product in terms of change in blood pressure of lower leg (standing or sitting).	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	To assess the effectiveness of the test product in terms of 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	To assess the effectiveness of the test product in terms of change in body leg temperature by Infrared camera (thermal image).	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	To assess the effectiveness of the test product in terms of overall improvement in symptoms and satisfaction with the use of test product using subjective perception questionnaire.	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.

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Collaborators: Winnox Cosmeceutics Sdn. Bhd
• Investigators: Principal Investigator: Dr. Nayan K Patel K Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): October 4, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 1, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins
• Other Study ID Numbers: NB240023-WU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No