Clinical trial NCT04837560: Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema
Official title: Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Edema Leg
Compression; Vein
Lead sponsor: ElastiMed ltd
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety Endpoint
timeFrame: Device operation hours during 10 business days
measure: Efficacy Endpoint
timeFrame: Device operation hours during 10 business days
Secondary outcomes:
measure: Secondary Efficacy Endpoint
timeFrame: Device operation hours during 10 business days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center at Tel HaShomer
Study officials:
affiliation: Sheba Medical Center at Tel HaShomer
name: Israel Dudkiewicz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: