| CTRI Number |
CTRI/2024/05/067222 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study of Nailfold capillaroscopy (Understanding Finger Blood Vessels) in Autoimmune Connective Tissue Disorders. |
|
Scientific Title of Study
|
A Study of Nailfold Capillaroscopy in Patients with Autoimmune Connective Tissue Disorders. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Henna Naresh Lalwani |
| Designation |
1st Year Resident Doctor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
GCSMCH and Research Centre, Department of Dermatology Venereolgy and Leprosy, Ground floor OPD no. 36, Opp.DRM office,Naroda road,Saraspur,Ahmedabad-380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9950921765 |
| Fax |
|
| Email |
drhenna.lalwani98@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna K Padhiyar |
| Designation |
Associate Professor |
| Affiliation |
GCS medical college hospital and research centre |
| Address |
GCSMCH and research centre, Department of Dermatology,Venereology and Leprosy, OPD no. 36, opp.DRM office, naroda road,saraspur, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8799417752 |
| Fax |
|
| Email |
dr.jignapadhiyar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigna K Padhiyar |
| Designation |
Associate Professor |
| Affiliation |
GCS medical college hospital and research centre |
| Address |
GCSMCH and research centre, Department of Dermatology,Venereology and Leprosy, OPD no. 36, opp.DRM office, naroda road,saraspur, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8799417752 |
| Fax |
|
| Email |
dr.jignapadhiyar@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCSMHC and Research Centre Opp. DRM office,Naroda road,Saraspur,Ahmedabad,380025 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Henna Lalwani |
GCS Medical College,Hospital and Research Centre |
GCSMCH and Research Centre, Department of Dermatology,Venereology and Leprosy, Opd no. 36 ,Ground floor, Opp. DRM office,Naroda Road,Saraspur, Ahmedabad-380025
Ahmadabad
GUJARAT |
09950921765
drhenna.lalwani98@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GCS medical college,hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M339||Dermatopolymyositis, unspecified, (2) ICD-10 Condition: M328||Other forms of systemic lupus erythematosus, (3) ICD-10 Condition: M351||Other overlap syndromes, (4) ICD-10 Condition: M32||Systemic lupus erythematosus (SLE), (5) ICD-10 Condition: M349||Systemic sclerosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed as a case of AICTD (Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Localised Scleroderma/ Morphea, Systemic sclerosis and Systemic Autoimmune Myopathies) will be included in this study. |
|
| ExclusionCriteria |
| Details |
1)Patients presenting of Primary Reynaud’s phenomenon-clinical examination as well as history and laboratory based evidence.
2)Patients of Secondary Reynaud’s Phenomenon caused due to factors such as occupational hazard or polyvinylchloride induced Reynaud’s Phenomenon.
3)Patients diagnosed with all other autoimmune connective tissue disorders that are not included in this study, such as Rheumatoid Arthritis, Antiphospholipid Antibody Syndrome,Mixed connective tissue Disorder, Vasculitis, Polymyalgia Rheumatica, Undiffrentiated Connective Tissue Disorder.
4)Patients who are not fulfilling the respective diagnostic criteria of the Autoimmune Connective Tissue Disorders.
5)Patient who are not willing to sign informed consent form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| â—To estimate the correlation between Nailfold Capillaroscopy Findings and severity scores in patients with AICTD. |
IT WILL BE ASSESED ON DAY O being a single visit observational study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To estimate the correlation between Nailfold Capillaroscopy findings & duration of the disorder.
2)To estimate the correlation between Nailfold Capillaroscopy findings & clinical features of the patient.
2)To estimate the correlation between laboratory parameters & Nailfold Capillaroscopy findings in patients with AICTD.
3)To estimate the difference in nailfold capillaroscopy findings between systemic sclerosis & localized scleroderma (Morphea), similarly among systemic lupus erythematosus (SLE) , subacute cutaneous lupus erythematosus (SCLE) & Chronic Cutaneous Lupus Erythematosus (CCLE).
|
IT WILL BE ASSESED ON DAY 0 being a single visit observational study. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/05/2024 |
| 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="2"
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
|
Nailfold Capillaroscopy is a safe, non-invasive method of
examination of microcirculation over the nail fold area of an individual. The
main role of Nailfold Capillaroscopy is to help in distinguishing a case of
primary Reynaud’s phenomenon from that of Secondary Reynaud’s phenomenon.
Nailfold Capillaroscopy is recognized to have useful clinical application in
patients suspected with Connective Tissue Disorders. This method helps in early
detection of microvasculature changes which may precede the clinical
manifestation of the disorders .It is thereby a helpful tool in clinical
diagnosis of autoimmune connective tissue disorders. Nevertheless, the
correlation of various Nailfold Capillaroscopy findings with that of the
severity of autoimmune connective tissue disorders is not well studied.
Hence, the purpose of this study is to correlate the Nailfold
Capillaroscopy findings of AICTD patients with severity scores of the
respective disorders. The AICTD included in this study with their respective
severity score include the following:
1.
Systemic Sclerosis -Medsger Severity Scale
2.
Systemic Lupus Erythematosus-SLEDAI2K Scale
3.
Discoid Lupus Erythematosus- Score of Activity
and Damage in DLE (SADDLE).
4.
Subacute Cutaneous Lupus Erythematous(SCLE)-
Cutaneous LE Disease Area and Severity Index (CLASI)
5.
Morphea-Localized Scleroderma Cutaneous
Assessment Tool
6.
Myositis- Myositis Disease Activity Assessment Tool(MDAAT)-2005 |