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CTRI Number  CTRI/2024/05/067346 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to determine the role of ankle brachial pressure index (index of blood pressure in the arms and legs )in diagnosing diabetic patients who have decreased blood flow in the lower limb blood vessels. 
Scientific Title of Study   Role of Ankle Brachial Pressure Index in the early diagnosis of Peripheral Vascular Disease in asymptomatic diabetic patients 
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 Aishwarya Solanki 
Designation  Junior Resident 
Affiliation  Department of General Surgery, Kasturba Medical College , Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharadha Madhav Pai OPD , Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9109608689  
Fax    
Email  aishwarya1.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayendra Kedage 
Designation  Associate Professor 
Affiliation  Department of General Surgery, Kasturba Medical College , Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharadha Madhav Pai OPD , Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9844680445  
Fax    
Email  vijayendra.kedage@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Ramesh Udupi 
Designation  Assistant Professor 
Affiliation  Department of General Surgery, Kasturba Medical College , Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharadha Madhav Pai OPD , Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9643488922  
Fax    
Email  vivek.udupi@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery, 3rd floor, Smt Sharadha Madhav Pai OPD,Kasturba Hospital Kasturba Medical College, Manipal 576104, Udupi Karnataka , India  
 
Primary Sponsor  
Name  Dr Aishwarya Solanki 
Address  Department of general surgery, 3rd floor, Smt Sharadha Madhav Pai OPD, Kasturba Hospital, Manipal 576104, Udupi Karnataka, India 
Type of Sponsor  Private medical college 
 
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 Aishwarya Solanki  Kasturba Hospital, Manipal Dept of general surgery and general medicine  Department of General surgery, 3rd Floor, Smt Sharadha Madhav Pal OPD, Kasturba Hospital , Manipal 576104
Udupi
KARNATAKA 
9109608689

aishwarya1.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I73||Other peripheral vascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 All Type 2 diabetic patients from the OPD and wards in Dept of General Surgery & Dept of
General Medicine who do not have PVD symptoms or signs like
Active ulcers
Absent peripheral pulses
Intermittent Claudication
Rest Pain
Skin changes like cold, shiny skin
Loss of hair on legs
Thickened or opaque toe nails
Gangrene
2 Previous healed ulcers
3 Patients giving consent to participate in the study.
4 Patients greater than 30 years of age.
5 Patients of both the genders.
6 Patients with peripheral neuropathy symptoms.
7 Patients with previous History of Myocardial Infarction, Stroke, TIA, CKD.
8 Patients with family history of arterial disease.
9 Smokers
 
 
ExclusionCriteria 
Details  1 Type 2 Diabetic patients who have already developed any symptoms suggestive of PVD.
2 Patients lesser than 30 years of age.
3 Patients with previous amputations
4 Patients with active ulcers. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Detect Peripheral Vascular Disease in asymptomatic diabetic patients using Ankle Brachial Pressure Index  The Ankle Brachial Pressure Index will be measured at the time of first contact with the patient in the OPD or ward, i.e. at Baseline only, which will take approximately 15-20 minutes. There will be no follow up of the patient. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine prevalence of PVD among Asymptomatic Diabetic Patients  After the sample size is reached in 18 months , prevalence of PVD among the diabetic patient will be calculated. 
 
Target Sample Size   Total Sample Size="203"
Sample Size from India="203" 
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)   24/05/2024 
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="1"
Months="6"
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  

Patients diagnosed as having Type 2 Diabetes Mellitus by a physician or patients on treatment for diabetes who don’t have symptoms of peripheral vascular disease will be approached in the OPD and Wards of both participating departments of general surgery and general medicine for participating in the study, will be explained the details of the study. Once the patient agrees, informed written consent will be taken. The case will then be recruited into the study. Basic demographic details will be obtained. We will assess the patients for duration of diabetes mellitus, other co morbidities, symptoms of peripheral neuropathy, history of Myocardial Infarction, HbA1c levels if available, family history of peripheral or coronary artery disease. Patient will then be asked to lie supine on bed and Systolic BP will be measured in both upper limbs and both lower limbs using sphygmomanometer with appropriate cuffs and handheld doppler device. The process will take about 10-20 minutes. The values will be charted in the Data collection proforma and Ankle Brachial Pressure Index will be calculated. Based on the obtained value and if the patient has ABPI<0.9, they’ll be counselled to go to concerned doctors for workup and further management of Peripheral vascular disease . If arterial doppler is done on the same admission, information will be obtained regarding the same. There will be no Follow up of the patients.

 
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