| CTRI Number |
CTRI/2026/01/102011 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to explore and compare Ankle Brachial Index values using Automated (Vasosense) and Doppler methods. |
|
Scientific Title of Study
|
Comparative Evaluation of Automated (Vasosense) ABI and Doppler ABI methods - A Cross-sectional Observational study. |
| Trial Acronym |
Automated vs Manual Ankle Brachial Index (ABI) Measurement: A comparative analysis of Vasosense ABI and Doppler ABI methods. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanchan P Sugandhi PT |
| Designation |
Assistant Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
HS219, CardioPulmonary Lab, College Of Physiotherapy
School of Health Sciences
Dayananda Sagar University
Devarakaggalahalli, Harohalli
Kanakapura Road, Bengaluru South Dt.
Bengaluru – 562 112
Bangalore
KARNATAKA
562112
India |
| Phone |
9755979947 |
| Fax |
|
| Email |
kanchan-physio@dsu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari Sharma K N |
| Designation |
Associate Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
HS219, CardioPulmonary Lab, College Of Physiotherapy
School of Health Sciences
Dayananda Sagar University
Devarakaggalahalli, Harohalli
Kanakapura Road, Bengaluru South Dt.
Bengaluru – 562 112
Bangalore
KARNATAKA
562112
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srihari Sharma K N |
| Designation |
Associate Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
HS219, CardioPulmonary Lab, College Of Physiotherapy
School of Health Sciences
Dayananda Sagar University
Devarakaggalahalli, Harohalli
Kanakapura Road, Bengaluru South Dt.
Bengaluru – 562 112
Bangalore
KARNATAKA
562112
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dayananda Sagar University |
| Address |
Devarakaggalahalli, Harohalli
Kanakapura Road, Bengaluru South Dt.
Bengaluru – 562 112
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayati Devices Pvt Ltd |
BLOCK A, 2nd Floor, DERBI Foundation, Dayanand Sagar University, Kudlu gate, Bangalore 560068 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srihari Sharma K N |
CDSIMER, Hoarohalli, Karnataka |
HS219, CardioPulmonary Lab, College Of Physiotherapy
School of Health Sciences
Dayananda Sagar University
Devarakaggalahalli, Harohalli
Kanakapura Road, Bengaluru South Dt.
Bengaluru – 562 112
Bangalore
KARNATAKA |
9886040520
srihari-physio@dsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, College of Physiotherapy, Dayanada Sagar University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I738||Other specified peripheral vascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DOPPLER ABI method using BP cuff and Doppler Ultrasound Device |
At baseline (Only once) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VASOSENSE ABI (an Automated device including 4 BP Cuffs for 4 limbs & software incorporated to measure BP) |
At baseline (Only once) |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |