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

Last updated: April 6, 2021
Sponsor: ElastiMed ltd
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04837560
CP-002
  • Ages 18-80
  • All Genders

Study Summary

Device Efficacy:

The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device.

Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time.

The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation.

The edema volume will be measured by a calf circumference measurement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must be between 18 to 80 years old

  2. Venous edema patients diagnosed by an indent in the skin following finger pressure.

  3. Venous edema in both calves

  4. Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion

  5. Subjects able to provide a written informed consent

  6. No existence of DVT according to leg deep vein Duplex test

Exclusion Criteria as reported by patients: :

  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

Study Design

Total Participants: 30
Study Start date:
April 01, 2021
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Sheba Medical Center at Tel HaShomer

    Ramat Gan, 52621
    Israel

    Active - Recruiting

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