| CTRI Number |
CTRI/2025/02/081045 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of venous Dopplers done prior to clinic visit with those done in the clinic |
|
Scientific Title of Study
|
Investigating Discrepancies Between Pre-Vascular Clinic and Vascular Clinic Venous Doppler Studies in Patients with Chronic Venous Insufficiency: A Single-Center Study
|
| 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 Prem Chand Gupta |
| Designation |
Clinical Director, Vascular Surgery |
| Affiliation |
Care Hospital, Banjara Hills |
| Address |
Department of Vascular Surgery, Care Hospital, Road No 1 Banjara Hills Hyderabad Road No 1, Banjara Hills, Hyderabad 500034 Hyderabad TELANGANA 500034 India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prem Chand Gupta |
| Designation |
Clinical Director, Vascular Surgery |
| Affiliation |
Care Hospital, Banjara Hills |
| Address |
Department of Vascular Surgery, Care Hospital, Road No 1 Banjara Hills Hyderabad Road No 1, Hyderabad 500034 Hyderabad TELANGANA 500034 India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prem Chand Gupta |
| Designation |
Clinical Director, Vascular Surgery |
| Affiliation |
Care Hospital, Banjara Hills |
| Address |
Department of Vascular Surgery, Care Hospital, Road No 1 Banjara Hills Hyderabad Road No 1, Banjara Hills, Hyderabad 500034 Hyderabad TELANGANA 500034 India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prem Chand Gupta, Department of Vascular Surgery, Care Hospital, Hyderabad 500034, Telangana, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Prem Chand Gupta |
| Address |
Department of Vascular Surgery, Care Hospital, Road No 1, Banjara Hills, Hyderabad, 500034, Telangana 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 Prem Chand Gupta |
Care Outpatient Center |
Room No 453, Department of Vascular Surgery, First floor, Care Outpatient Center, Road No 10, Banjara Hills, Hyderabad Hyderabad TELANGANA |
9848053220
vasculartherapy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Care Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
00 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients coming with varicose veins and Duplex scan done at another center. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Duplex scan findings in terms of reflux |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identify variables associated with discrepancies
Assess change in clinical management
Identify association between discrepancies & specific Doppler measurements
|
at time of first evaluation |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
03/03/2025 |
| 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="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
|
Venous Doppler ultrasound is a critical diagnostic tool used to evaluate venous conditions such as chronic venous insufficiency (CVI). Many patients who are referred to the vascular clinic come in with prior venous Dopplers, and later have another venous Doppler done as part of the vascular clinic visit. However, disparities in Doppler findings may occur due to variations in technique, equipment, examiner experience, or patient factors between external Dopplers and those performed in a vascular clinic. These disparities can cause inefficiencies in patient care and impact clinical management and patient outcomes. This study aims to investigate the presence and extent of discrepancies between pre-vascular clinic and vascular clinic Doppler studies, identify contributing factors, and evaluate the clinical implications of these differences. A prospective cohort analysis will be conducted on patients who had both pre-vascular clinic and vascular clinic Doppler studies. Data on patient demographics, clinical characteristics, and Doppler parameters (e.g., peak systolic velocity, reflux time, and anteroposterior diameter for key venous segments) will be analyzed. Statistical methods will include paired comparisons, logistic regression, and subgroup analysis to identify factors associated with Doppler discrepancies and assess their clinical impact. The study will highlight key sources of variability between pre-vascular clinic and vascular clinic venous Doppler studies, and allow us to propose solutions to facilitate greater diagnostic accuracy. Research Question/Hypothesis: The purpose of this study is to determine the extent of disparity between pre-vascular clinic visit venous Doppler and vascular clinic visit venous Doppler. We hypothesize that there is a significant discrepancy between pre-vascular clinic and vascular clinic venous Doppler findings in terms of assessment of superficial venous reflux which can cause inefficiency in patient care and influence clinical decision-making and patient outcomes. Patient comorbidities, type of facility, and interpreting professional’s experience are hypothesized to be significant predictors of these discrepancies. Primary: - Determine if there is a discrepancy between Pre-vascular visit Venous Doppler and Vascular Venous Doppler Studies in Patients with Chronic Venous Insufficiency based on venous Doppler parameters and clinical outcomes
Secondary: - Identify variables associated with discrepancies
- Assess change in clinical management
- Identify association between discrepancies and specific Doppler measurements
|