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

Edema Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837560
• Other study ID #: CP-002
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: ElastiMed ltd
• Contact: Vered Shuster, PhD
• Phone: +972-54- 6819828
• Email: vered[@]elastimed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Compression; Vein
• Edema
• Edema Leg

Intervention

Device:
• ElastiMed's SACS 2.0
A wearable medical device that improve circulation using smart materials

Locations

Country	Name	City	State
Israel	Sheba Medical Center at Tel HaShomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
ElastiMed ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint	Accumulative rate of device related SAEs throughout the trial duration.	Device operation hours during 10 business days
Primary	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	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