| CTRI Number |
CTRI/2025/12/099043 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk of Peripheral Arterial Disease (PAD) among the patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A descriptive study to identify the risk and assess the knowledge on Peripheral Arterial Disease (PAD) among the patients with Type 2 Diabetes Mellitus at selected tertiary care hospital of Udupi district, Karnataka |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Lavanya |
| Designation |
MSc Student |
| Affiliation |
Manipal College of Nursing |
| Address |
400A, 4th floor, Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal,udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9493383251 |
| Fax |
|
| Email |
lavanyapera4169@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Sequira |
| Designation |
Principal |
| Affiliation |
Manipal school of Nursing |
| Address |
Manipal School of Nursing, Manipal Academy of Higher Education (MAHE), Manipal,udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7337717214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Agin Jiju RJ |
| Designation |
Lecturer |
| Affiliation |
Manipal College of Nursing |
| Address |
5th floor, Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal,udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7356350275 |
| Fax |
|
| Email |
Agin.joice@manipal.edu |
|
|
Source of Monetary or Material Support
|
| OPD Department of Endocrinology, Kasturba Hospital, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
P Lavanya |
| Address |
400A, 4th floor, Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal- 576104,udupi, Karnataka, India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahana Shetty |
Kasturba Hospital |
OPD Department of Endocrinology, Kasturba Hospital, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
Udupi
KARNATAKA |
9944745014
sahana.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethical committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The research participants
Diagnosed with Type 2 diabetes mellitus visiting endocrinology OPD
Age above 45 years both men and women |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with PAD
Patients with leg ulcers and presence of gangrene
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge, peripheral Arterial disease |
Base line Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="423"
Sample Size from India="423"
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)
|
24/12/2025 |
| 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="2"
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
|
Introduction:
According to the results of the current literature review and studies conducted to gauge the prevalence of PAD in different parts of the world and the country, the disease’s burden is rising quickly. Numerous factors have been linked to the development of PAD and an increase in the population’s risk of cardiovascular issues, which highlights the urgent need for a variety of control strategies.
Title: A descriptive study to identify the risk and assess the knowledge on Peripheral Arterial Disease (PAD) among the patients with Type 2 Diabetes Mellitus at selected tertiary care hospital of Udupi district, Karnataka.
Aims and objectives:
The aim of this research is to assess the knowledge regarding PAD and to identify the risk of PAD among Type 2 Diabetes Mellitus patients. The study is purposed to provide awareness to the patients about PAD and Buerger Allen exercise which will help to prevent and reduce the risk of developing PAD by providing a leaflet. And the objectives of the study are to assess the level of knowledge on PAD using structured questionnaire, to identify the risk of Peripheral Arterial Disease using Ankle Brachial index (ABI) scale, to determine the association between knowledge of PAD and selected socio- demographic factors, to find out the relationship between knowledge and risk of PAD. |