Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema

Exclusion Criteria

• •1. Positive pregnancy test
• •2. Breastfeeding woman
• •3. moderate or severe Congestive heart failure
• •4. Cellulitis of tissues of the lower limb.
• •5. Infectious Dermatitis of the lower limb
• •6. Acute or within 6 weeks of a deep vein thrombosis (DVT).
• •7. Postphlebetic patients
• •8. Known hypersensitivity to any component of the device
• •9. Subjects unable to provide informed consent
• •10. Active cancer at the root of the limb or in the adjacent quadrant
• •11. Any limitation of renal function- according to the investigator's discretion
• •12. Any limitation of liver function - according to the investigator's discretion
• •13. Subject who cannot commit to a month of intensive standard therapy
• •14. Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
• •15. Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
• •16. Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments
• •17. Cardiac or cerebral pacemaker or stimulator
• •18. Patients after orthopedic / vascular injury in the lower extremities