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Ø The study will be
conducted in the OPD of
Dermatology,Venereology&
Leprosy department at Sir-T
hospital,Bhavnagar.
Study procedures:
Details of procedures
along with Inclusion & exclusion criteria
Details of study groups, intervention, follow up,
randomization, blinding, etc - Ø After the patient comes to Opd, diagnosis of DM
to be made according to ADA critera
Ø Then the patient will be assessed for
eligibility
Ø Relevant history will be taken and the patients will be subjected to
relevant tests like
Ø Fundoscopic examination
Ø HbA1c levels
Ø NFC will be performed when the
patient will come with relevant reports.
Ø Nailfold capillaroscopy images will
be taken by Firefly 330T dermoscope. Images of all 10 fingers will be included
in the study.
Ø Procedure will be carried out with the hands
placed at a heart level and in a seated position.
Ø For the examination of each finger, a drop of
immersion oil was placed in the nailfold to improve visibility. The capillaries
were observed with a 100x magnification capillaroscope (Firefly 330T) and
photographs were taken of the last distal row of the capillaries.
Ø Data will be entered in excel file.
Analysis will be done.
Ø
Ø Inclusion criteria :
Ø All newly diagnosed and Established diagnosis
of Type II Diabetes Mellitus according to the criteria of the American Diabetes
Association (ADA)(2).
Ø Age group 20-60 years
Ø Exclusion criteria :
Ø Pregnant or lactating women
Ø Suffering from other nail conditions
(e.g., psoriasis) which might interfere in the interpretation of results
Ø Use of nail paint, nail acrylic or
any cosmetic on the nail.
Ø Patient suffering from hypertension
or other cardiac co-morbidities
Ø Preexisting disease that affects
vascular architecture like Raynauds Phenomenon, Systemic Sclerosis, SLE ad
other connective tissue diseases.
Ø Patients with a history of Smoking
or Trauma in the periungual fold.
Ø Patients with onychophagia,
onychotillomania, with any other nail disease.
Outcome
variables - Capillaroscopic 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
•
Ramified
capillaries - they were described as those capillaries that adopt the shape
similar to a tree.
•
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.
•
Dominant
morphology - finding that predominates in more than 20%, whether its open,
tortuous or crosslinked.
•
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
•
Cuticulitis - inflammation of the insertion of the
cuticle at the periungual fold.
•
SD pattern
- presence of: giant capillaries,
avascular zones, haemorrhages and ramified capillaries all together.
•
Receding capillaries - were seen as individual
capillaries maintaining their position in the distal‑most row but presenting
slightly proximal to the distal‑most loops
•
Angulated capillaries - were a special type of
tortuous capillary where one or both the arms of the distal capillary loop were
seen to bend at an angle
Statistical methods
Data analysis
plan: Type of data, - Ø Studied data will be
analysed and compiled in master chart.
Ø After tabulation of
data,statistical analysis will be done.
Ø The categorical variable
will be analysed by number,percentage,frequency.
Ø Chi-square will be applied
wherever required.
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