Skip to main content
Clinical Trials/CTRI/2021/01/030228
CTRI/2021/01/030228Not yet recruitingNot Applicable

“Nailfold Capillaroscopy in healthy volunteers - Observational Studyâ€

Dr Gorasiya Amitkumar Rameshbhai1 site in 1 country100 target enrollmentStarted: March 29, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Haemorrhages

Study Overview

Brief Summary

Title "Nailfold Capillaroscopy in normal people - Observational Study"

Introduction & review of LiteratureNailfold capillaroscopy is reproducible, noninvasive, painless, and inexpensive technique for studying proximal nailfold (PNF) capillaries

Nailfold capillaroscopy (NFC) is used in peripheral microcirculation ,primary and secondary raynaud’s phenomenon, systemic sclerosis , diabetics and hypertensive vasculopathy

The interpretation of NFC data is restricted by the paucity of studies in normal individuals.

NFC findings may be influenced by age, ethnicity, geographic region, inter-observer variation and differences in skin transparency (owing to skin pigmentation, hyperkeratosis, injuries, edema, etc.)

Research Question

What are the nailfold capillaroscopy findings in normal people?

Abnormal Nailfold Capillaroscopy finding in normal people

What is Differences in nail fold capillaries finding in different age-group and sex?

Aim/Goal To study the Nailfold Capillaries pattern in normal people

Objectives:

Primary:

to describe the morphological characteristics of nail fold capillaries in normal people

Secondary:

To assess the baseline parameters in nailfold capillaroscopy so that the normal and abnormal change in NFC can be differentiated and it’s association with the other disease can be made.

Standardised common different in both sex and age group

Study design/typeThis will be an Observational, cross-sectional study

Study populationHealthy individual accompanying patients in dermatology opd , hospital staff (medical ,paramedical, administrative, supporting staff) undergraduate posted in department of dermatology

Sample size 100

Study duration 12month

Study site. OPD of Dermatology,Venereology& Leprosy department at Sir-T

hospital,bhavnagar.

Study procedures Nailfold Capillaroscope – NFC will be performed on all 10 fingers.

Instrument to used – Dermoscope it will be connected to a computer. The images will be taken and recorded on the same device.

Method - This observational, analytical study will be conducted in Department of Dermatology sir t hospital (medical College) bhavangar Gujarat India

healthy individual accomplainig patients in dermatological department hospital staff (medical ,paramedical, adminstrative, supporting staff) undergraduate posted in dermatology department

Individuals are selected as per Convenience sampling and Inclusion and exclusion criteria will be applie examinationn of all 10 nails was performed in all study subjects.

Each volunteer was made to sit comfortably at an ambient Room temperature for 15 min and then subjected to a detailed NFC on all 10 fingernails with the hands placed on a dull non-refractile surface at the level of heart. The polarizing dermatoscop (immersion oil). NFC was performed by a single observer (AR) at higher magnification (100 X) for assessing the detailed morphology of the capillariesThe images were stored, processed and interpreted by observers

Inclusion criteria :

Normal people.

Age group 20-60 years

Exclusion criteria :

Pregnant or lactating women

FBS > 126 according to ADA guidelines for diabetics OR any past history of diabetes

Suffering from other nail conditions (e.g., psoriasis) which might interfere in the interpretation of results

Patient on with any drug history pertaining to cause vascular changes like vasodilators etc.

Use of nail paint, nail acrylic or any cosmetic on the nail.

Patient suffering from hypertension or other cardiac co-morbidities

Pre existing disease that affects vascular architecture like Raynaud’s Phenomenon, Systemic Sclerosis, SLE ad other connective tissue diseases.

Patients with a history of Smoking or Trauma in the periungual fold.

Patients with onychophagia, onychotillomania , with any other nail disease

Outcome variablesCapillaroscopic Findings related to morphology and arrangement of vessles as well as any new parameters will be looked for and its further comparison and correlation will be done (its Dummy tables available in ppt). The presence or absence of the following parameters will be recorded:-

Dilated/Giant capillaries - width of the capillary >2 times or >10 times the normal, respectively

Neoangiogenesis/bushy capillaries - small, multiple buds originating from the distal loop

Meandering capillaries - limbs crossed upon themselves several times

Tortuous capillaries - capillary limb curled but not crossing over

Avascular zones - absence of two or more adjacent capillaries from the distal‑most row

Haemorrhages - as the hemosiderin deposit, caused by the rupture of one or more capillaries.

Bizarre Capillaries - atypical morphology not conforming to the predefined morphologies

Visibility of the subpapillar venous plexus - a network of larger vessels with respect to the capillaries.

presence of the parameter was determined accordingly. 0: not visible 1: doubtful or limited visibility 2: Plexus visible in certain areas 3: Fully visible in large areas

Capillary drop out - absence of capillary Loop

Statistical methodsData analysis plan

Studied data will be analysed and compiled in master chart.

After tabulation of data,statistical analysis will be done.

The categorical variable will be analysed by number,percentage,frequency.

Chi-square will be applied wherever required

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Normal people.

Exclusion Criteria

  • Pregnant or lactating women Suffering from other nail conditions (e.g., psoriasis) which might interfere in the interpretation of results Use of nail paint, nail acrylic or any cosmetic on the nail.
  • Patient suffering from hypertension or other cardiac co-morbidities Preexisting disease that affects vascular architecture like Raynauds Phenomenon, Systemic Sclerosis, SLE ad other connective tissue diseases.
  • Patients with a history of Smoking or Trauma in the periungual fold.
  • Patients with onychophagia, onychotillomania, with any other nail disease.

Outcomes

Primary Outcomes

Haemorrhages

Time Frame: Once

Changes if nailfold capillaries will be observed via capillaroscope in normal people and will be seen according to the following parameters

Time Frame: Once

Dilated/Giant capillaries

Time Frame: Once

Meandering capillaries

Time Frame: Once

Tortuous capillaries

Time Frame: Once

Avascular zones

Time Frame: Once

Capillaries Visibility of the subpapillar venous plexus

Time Frame: Once

Neoangiogenesis/bushy capillaries

Time Frame: Once

Secondary Outcomes

  • To assess the baseline parameters in nailfold capillaroscopy so that the normal and abnormal change in NFC can be differentiated and its association with the other disease can be made.(Standardised common different in both sex and age group)

Investigators

Sponsor
Dr Gorasiya Amitkumar Rameshbhai
Sponsor Class
Other [self]

Study Sites (1)

Loading locations...

Similar Trials