Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Edema reduction
研究概览
简要总结
Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days.
详细描述
The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging.
The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic edema of the lower limb
- •Referred to compression bandaging
- •Circumference of widest point of the lower leg between 35-75 cm
排除标准
- •Wounds at the lower leg (at the widest circumference of the lower leg)
- •Acute deep venous thrombosis in the leg
- •Untreated cellulitis
- •Severe heart- or kidneyfailure
- •Severe peripheral neuropathy in the lower limbs
结局指标
主要结局
Edema reduction
时间窗: 14 days
Assessed by Cimon sensor (in capacitans, pF)
次要结局
- Edema reduction(14 days)
- Physical Activity (PA)(14 days)
- Adverse events(14 days)
- Symptoms related to chronic edema(14 days)
研究者
Carsten Bogh Juhl
Professor
Herlev and Gentofte Hospital