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CTRI Number  CTRI/2021/03/032398 [Registered on: 30/03/2021] Trial Registered Prospectively
Last Modified On: 30/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of cutaneous vasculitis 
Scientific Title of Study   Clinico-dermoscopic, histopathological and immunological correlation of cutaneous vasculitis in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja R Uppoor 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Mangalore,Affliated to MAHE 
Address  Department of Dermatology OPD No.10,First floor ,KMC Hospital,Attavar,Mangalore Dakshina Kannada KARNATAKA 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9481054261  
Fax    
Email  pooja.uppoor@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Pooja R Uppoor 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Mangalore,Affliated to MAHE 
Address  Department of Dermatology OPD No.10,First floor ,KMC Hospital,Attavar,Mangalore Dakshina Kannada KARNATAKA 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9481054261  
Fax    
Email  pooja.uppoor@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DR Gatha M Upadya 
Designation  Head Of Department 
Affiliation  Kasturba Medical College, Mangalore,Affliated to MAHE 
Address  Department of Dermatology OPD No. 10,First floor,KMC Hospital,Attavar,Mangalore Dakshina Kannada KARNATAKA 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845314028  
Fax    
Email  gatha.upadya@manipal.edu  
 
Source of Monetary or Material Support  
Indian Association of Dermatologists, Venereologists and Leprologists 
 
Primary Sponsor  
Name  Indian Association of Dermatologists Venereologists and Leprologists 
Address  IADVL National Headquarters 314-315, 3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh. 201010 
Type of Sponsor  Other [PG THESIS GRANT] 
 
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 Pooja R Uppoor  KMC Hospital and Hospitals attached to it  1)Dermatology OPD No10, First floor, KMC Hospital Attavar Mangalore 575001 2)Dermatology OPD No 35, first floor Government Wenlock Hospital Mangalore 575001 3)Dermatology OPD Room No 16, KMC Hospital , Ambedkar circle Mangalore 575001
Dakshina Kannada
KARNATAKA 
9481054261

pooja.uppoor@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L959||Vasculitis limited to the skin, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:
1. Patients who are willing to give informed written consent for enrollment into the study.
2.All patient with clinical features suggestive of cutaneous vasculitis
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1.Patient with thrombocytopaenia
2.Patients with coagulation disorders
3.Patients on warfarin /heparin
4.Patients who are not willing to give consent

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Based on clinical, dermoscopic, histopathological and DIF findings   baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Etiology of cutaneous vasculitis
Clinical features of cutaneous vasculitis
Dermoscopic features of cutaneous vasculitis
histopathological features of cutaneous vasculitis
DIF features of cutaneous vasculitis 
baseline 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   31/03/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM OF THE STUDY: To study the epidemiology and correlation between clinically diagnosed Cutaneous Vasculitis with its histopathological and direct immunofluorescence findings.

 OBJECTIVES OF THE STUDY:

1.     To study the clinical features of cutaneous vasculitis.

2.     To find out the etiology of cutaneous vasculitis

3. To study the correlation between the clinical features, histopathological and direct immunofluorescence findings of cutaneous vasculitis.

METHODOLOGY:

STUDY SETTING:Patients coming to the dermatology OPD of teaching hospitals attached to Kasturba Medical College, Mangalore (KMC hospital, Attavar and Government Wenlock hospital).

STUDY DESIGN: It’s a time bound study, cross-sectional and non-interventional study

INCLUSION CRITERIA:

1.     Patients who are willing to give informed written consent for enrollment into the study.

2.     All patient with clinical features suggestive of cutaneous vasculitis

EXCLUSION CRITERIA:

1.     Patient with thrombocytopaenia

2.     Patients with coagulation disorders

3.     Patients on warfarin /heparin

4.     Patients who are not willing to give consent

STUDY DURATION18 months

SAMPLING METHODConvenience sampling

OUTCOME: Based on clinical, histopathological and DIF findings 

DATA COLLECTION TOOL AND ANALYSIS: Patients attending dermatology OPD with clinical features of cutaneous vasculitis will be taken into study. Detailed history will be taken. Detailed cutaneous examination will be performed, and findings will be noted in the proforma. Dermoscopic examination was done using a DermLite-3 (3Gen, San Juan Capistrano, CA) dermoscope.  Consent will be taken from the patient for biopsy after explaining the procedure. Necessary blood investigations will be carried out all the reports will be entered into the proforma and then into excel sheet.

ANALYSIS:

1.Data will be entered in Microsoft Excel and analyzed using Statistical Product and Service Solution (SPSS) version 25.


 
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