Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety Endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Safety Endpoint
时间窗: Device operation hours during 10 business days
Accumulative rate of device related SAEs throughout the trial duration.
Efficacy Endpoint
时间窗: 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
次要结局
- Secondary Efficacy Endpoint(Device operation hours during 10 business days)