| 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
|
|
|
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
|
|
|
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. |