Varicose Veins With Self-declared Knee Pain Clinical Trial
Official title:
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.
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. ;