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CTRI Number  CTRI/2025/07/091173 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative study 
Study Design  Single Arm Study 
Public Title of Study   By comparing ABI we will find risk of peripheral arterial disease 
Scientific Title of Study   Comparison of Ankle Brachial Index in hypertensive individuals with different morbidities. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreya Dhake 
Designation  HOD and Asso. professor 
Affiliation  DES Brijlal Jindal college of physiotherapy 
Address  Department of cardiovascular and respiratory physiotherapy, DE society Brijlal Jindal college of physiotherapy, Fergusson college campus, shivaji nagar.

Pune
MAHARASHTRA
411004
India 
Phone  9892252731  
Fax    
Email  shreya.dhake@despune.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Anvi Hajare PT 
Designation  postgraduate student 
Affiliation  DES Brijlal Jindal college of physiotherapy 
Address  DE society Brijlal Jindal college of physiotherapy, Fergusson college campus, shivaji nagar, pune.

Pune
MAHARASHTRA
411004
India 
Phone  09822695617  
Fax    
Email  anvihajare16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anvi Hajare PT 
Designation  postgraduate student 
Affiliation  DES Brijlal Jindal college of physiotherapy 
Address  DE society Brijlal Jindal college of physiotherapy, Fergusson college campus, shivaji nagar, pune.

Pune
MAHARASHTRA
411004
India 
Phone  09822695617  
Fax    
Email  anvihajare16@gmail.com  
 
Source of Monetary or Material Support  
DES Brijlal jindal college of physiotherapy, Fergusson college campus, pune 
 
Primary Sponsor  
Name  Anvi Arvind Hajare 
Address  DES Brijlal jindal college of physiotherapy, Fergusson college campus, pune 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anvi Hajare PT  DES brijlal jindal college of physiotherapy Fergusson college campus, pune   DE society Brijlal Jindal college of physiotherapy, Fergusson college campus, shivaji nagar, pune.
Pune
MAHARASHTRA 		 09822695617

anvihajare16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
D.E.Society BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Hypertensive Individuals.
2.Age above 40 years.
3.Both Genders M/F
4.Hypertensive individuals having morbidities like diabetes mellitus, heart diseases, obesity, chronic kidney diseases, respiratory diseases, smokers.
 
 
ExclusionCriteria 
Details  1.Known case of Peripheral arterial diseases.
2.Lower limb fractures/ skin conditions where the palpation is not possible 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ankle brachial index.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
nill   
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
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)   30/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   In 159 hypertensive individuals the aim of the study is to find out risk of having peripheral arterial diseases in which they have different morbidities like  diabetes, heart failure, obesity, chronic kidney disease, respiratory diseases, smokers. Ankle brachial index is a simple non invasive test that measures blood pressure of lower extremity to upper extremity. patient will be selected on the basis of inclusion and exclusion criteria. the informed concent of participants will be obtained explaining the procedure of the study. individuals having different levels of morbidities in which the individual may have single morbidity or more than one morbidity the values of ABI will be measured . Individuals having different levels of morbidity in which the individual may have single morbidity or more than one morbidity the value of ABI will be measured.  Ankle brachial index will be determined from blood pressure measurement in both upper limb and ankle with subject in supine/ Sitting position.   Systolic blood pressure from the brachial artery in the cubital fossa is measured using a blood pressure cuff and stethoscope and in the lower limb systolic blood pressure from the posterior tibial artery or dorsalis pedis artery is measured with scope detection by placing a blood pressure cuff just about the malleoli at the ankle.   The ABI calculation is obtained by the ratio of higher systolic blood pressure of ankle to the higher systolic blood pressure of arm. For three times the measurement is taken from single individual. And the lowest values of ABI will be going to be considered as the final value. 
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