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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L959||Vasculitis limited to the skin, unspecified, |
|
Intervention / Comparator Agent
|
|
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 DURATION: 18 months SAMPLING METHOD: Convenience 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. |