Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Temporarily or permanently wheelchair users which suffer from Venous Edema 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be between 18 to 80 years old
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Venous edema patients diagnosed by an indent in the skin following finger pressure.
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Venous edema in both calves
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Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
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Subjects able to provide a written informed consent
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No existence of DVT according to leg deep vein Duplex test
Exclusion Criteria as reported by patients: :
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Positive pregnancy test
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Breastfeeding woman
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moderate or severe Congestive heart failure
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Cellulitis of tissues of the lower limb.
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Infectious Dermatitis of the lower limb
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Acute or within 6 weeks of a deep vein thrombosis (DVT).
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Postphlebetic patients
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Known hypersensitivity to any component of the device
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Subjects unable to provide informed consent
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Active cancer at the root of the limb or in the adjacent quadrant
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Any limitation of renal function- according to the investigator's discretion
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Any limitation of liver function - according to the investigator's discretion
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Subject who cannot commit to a month of intensive standard therapy
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Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
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Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
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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
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Cardiac or cerebral pacemaker or stimulator
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Patients after orthopedic / vascular injury in the lower extremities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheba Medical Center at Tel HaShomer | Ramat Gan | Israel | 52621 |
Sponsors and Collaborators
- ElastiMed ltd
Investigators
- Principal Investigator: Israel Dudkiewicz, Prof., Sheba Medical Center at Tel HaShomer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-002