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

Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking

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.

Study Overview

• Status: Recruiting
• Conditions: Compression; Vein; Edema Leg
• Intervention / Treatment: Device: ElastiMed's SACS 2.0

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vered Shuster, PhD; Phone Number: +972-54- 6819828; Email: vered@elastimed.com
• Study Contact Backup: Name: Omer Zelka; Phone Number: +972-52- 6339131; Email: omer@elastimed.com

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center at Tel Hashomer
    • Contact: Israel Dudkiewicz, Prof
    • Contact: Doc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temporarily or permanently wheelchair users which suffer from Venous Edema	Device: ElastiMed's SACS 2.0; A wearable medical device that improve circulation using smart materials

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint	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	Device operation hours during 10 business days

Collaborators and Investigators

• Sponsor: ElastiMed ltd
• Investigators: Principal Investigator: Israel Dudkiewicz, Prof., Sheba Medical Center at Tel Hashomer

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: CP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No