Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- ElastiMed ltd
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Efficacy Endpoint
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must be between 18 to 80 years old
- •Venous edema patients diagnosed by an indent in the skin following finger pressure.
- •Venous edema in both calves
- •Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
- •Subjects able to provide a written informed consent
- •No existence of DVT according to leg deep vein Duplex test
Exclusion Criteria
- •as reported by patients: :
- •Positive pregnancy test
- •Breastfeeding woman
- •moderate or severe Congestive heart failure
- •Cellulitis of tissues of the lower limb.
- •Infectious Dermatitis of the lower limb
- •Acute or within 6 weeks of a deep vein thrombosis (DVT).
- •Postphlebetic patients
- •Known hypersensitivity to any component of the device
- •Subjects unable to provide informed consent
- •Active cancer at the root of the limb or in the adjacent quadrant
- •Any limitation of renal function- according to the investigator's discretion
- •Any limitation of liver function - according to the investigator's discretion
- •Subject who cannot commit to a month of intensive standard therapy
- •Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
- •Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
- •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
- •Cardiac or cerebral pacemaker or stimulator
- •Patients after orthopedic / vascular injury in the lower extremities
Arms & Interventions
Temporarily or permanently wheelchair users which suffer from Venous Edema
Temporarily or permanently wheelchair users which suffer from Venous Edema
Intervention: ElastiMed's SACS 2.0 (Device)
Outcomes
Primary Outcomes
Efficacy Endpoint
Time Frame: 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
Safety Endpoint
Time Frame: Device operation hours during 10 business days
Accumulative rate of device related SAEs throughout the trial duration.
Secondary Outcomes
- Secondary Efficacy Endpoint(Device operation hours during 10 business days)