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

Phase 1

• Conditions: Edema Leg; Compression; Vein
• Interventions: Device: ElastiMed's SACS 2.0

• Registration Number: NCT04837560
• Lead Sponsor: ElastiMed ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Temporarily or permanently wheelchair users which suffer from Venous Edema	ElastiMed's SACS 2.0	Temporarily or permanently wheelchair users which suffer from Venous Edema

Primary Outcome Measures

Name	Time	Method
Safety Endpoint	Device operation hours during 10 business days	Accumulative rate of device related SAEs throughout the trial duration.
Efficacy Endpoint	Device operation hours during 10 business days	To demonstrate the efficacy by following the edema volume reduction after device application, in venous edema subjects, by measuring the calf circumference

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Endpoint	Device operation hours during 10 business days	To demonstrate the efficacy by changing the edema volume after using the SACS 2.0 device at least as much as after using a compression bandage

Trial Locations

Locations (1)

Sheba Medical Center at Tel HaShomer; 🇮🇱 Ramat Gan, Israel