A Study of Nailfold Capillaroscopy in Patients with Autoimmune Connective Tissue Disorders.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- â—To estimate the correlation between Nailfold Capillaroscopy Findings and severity scores in patients with AICTD.
Study Overview
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients presenting of Primary Reynaud’s phenomenon-clinical examination as well as history and laboratory based evidence.
- •Patients of Secondary Reynaud’s Phenomenon caused due to factors such as occupational hazard or polyvinylchloride induced Reynaud’s Phenomenon.
- •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.
- •Patients who are not fulfilling the respective diagnostic criteria of the Autoimmune Connective Tissue Disorders.
- •Patient who are not willing to sign informed consent form.
Outcomes
Primary Outcomes
â—To estimate the correlation between Nailfold Capillaroscopy Findings and severity scores in patients with AICTD.
Time Frame: IT WILL BE ASSESED ON DAY O being a single visit observational study
Secondary Outcomes
- 1)To estimate the correlation between Nailfold Capillaroscopy findings & duration of the disorder.
Investigators
Henna Naresh Lalwani
GCS Medical College Hospital and Research Centre