Comparative Evaluation of Automated (Vasosense) ABI and Doppler ABI methods - A Cross-sectional Observational study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- DOPPLER ABI method using BP cuff and Doppler Ultrasound Device
研究概览
简要总结
This study is aimed to evaluate the clinical utility and accuracy of the Vasosense ABI, an automated ankle-brachial index (ABI) measurement device, by comparing its readings with Doppler-detected ABI measurements in the same patient population. The Vasosense ABI is intended for the automated measurement of the ankle-brachial index (ABI) to assess peripheral arterial circulation. It is designed to aid in the screening, diagnosis, and monitoring of peripheral arterial disease (PAD). Vasosense ABI operates on the oscillometric blood pressure measurement principle, an automated method for determining systolic and diastolic blood pressure. The device integrates four automatic BP machines to simultaneously capture pressure readings at the brachial and ankle arteries, with data processed through a mobile application that calculates the ankle-brachial index (ABI).ABI offers a fully automated, observer-independent approach, improving efficiency, reproducibility, and accessibility in clinical settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will include the following groups of participants Healthy adult subjects more than 18 years with no known vascular disease.
- •Patients with risk factors for peripheral arterial disease (e.g., diabetes, hypertension) but without known PAD.
- •Patients with confirmed peripheral arterial disease (PAD), diagnosed based on clinical criteria.
排除标准
- •Participants will be excluded if they have: History of other medical conditions known to affect vascular function, including: Advanced chronic kidney disease (CKD) Connective tissue disorders (e.g., systemic lupus erythematosus, scleroderma) Vasculitis or other inflammatory vascular conditions Buerger’s disease Severe anemia or polycythemia Hypercoagulable states Use of vasoactive medications that could affect blood pressure readings (e.g., high-dose beta-blockers, vasodilators).
- •History of major lower limb amputation or previous vascular surgery affecting ABI measurements.
- •Severe limb edema or wounds/ulcers at the measurement site.
- •Critical limb ischemia (CLI), defined by resting pain, non-healing ulcers, or gangrene.
- •Inability to provide informed consent.
- •Pregnancy or lactation.
结局指标
主要结局
DOPPLER ABI method using BP cuff and Doppler Ultrasound Device
时间窗: At baseline (Only once)
次要结局
- VASOSENSE ABI (an Automated device including 4 BP Cuffs for 4 limbs & software incorporated to measure BP)(At baseline (Only once))
研究者
Dr Kanchan P Sugandhi PT
Dayananda Sagar University