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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  
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 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  
Status 
Not Applicable 
 
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 
 
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