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An observational study to explore and compare Ankle Brachial Index values using Automated (Vasosense) and Doppler methods.

Comparative Evaluation of Automated (Vasosense) ABI and Doppler ABI methods - A Cross-sectional Observational study. - Automated vs Manual Ankle Brachial Index (ABI) Measurement: A comparative analysis of Vasosense ABI and Doppler ABI methods.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/102011
Enrollment
75
Registered
2026-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I738- Other specified peripheral vascular diseases

Interventions

Intervention1: Nil: Nil Control Intervention1: VASOSENSE Automatic ABI: The Vasosense ABI is intended for the automated measurement of the ankle-brachial index (ABI) to assess peripheral arterial circ

Sponsors

Dayananda Sagar University
Lead Sponsor
Ayati Devices Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
DOPPLER ABI method using BP cuff and Doppler Ultrasound DeviceTimepoint: At baseline (Only once)—

Secondary

MeasureTime frame
VASOSENSE ABI (an Automated device including 4 BP Cuffs for 4 limbs & software incorporated to measure BP)Timepoint: At baseline (Only once)—

Countries

India

Contacts

Public ContactDr Srihari Sharma K N

Dayananda Sagar University

srihari-physio@dsu.edu.in9886040520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026