“Nailfold Capillaroscopy to assess microcirculation in patients of Diabetes Mellitus, an Observational Studyâ€

Title of theProject/Thesis/Dissertation:

“NailfoldCapillaroscopy to assess microcirculation in patients of Diabetes Mellitus, anObservational Studyâ€

Introduction

•       Diabetes is currently considered a chronicdisease with a high mortality rate due to its longterm cardiovascular and renalcomplications.

•       Data from the Diabetes Control andComplications Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS) showsthat chronic hyperglycemia is the most important risk factor for thedevelopment of microvascular complications in patients with type I and IIdiabetes mellitus and that endothelial dysfunction plays an important role inthe development of vascular diseases and represents the initial stage inpathogenesis of the disease.

•       The current trend for evaluating microvasculardamage in diabetic patients is the use of: Doppler flowmetry, direct andindirect ophthalmoscopy, ambulatory blood pressure monitoring, but capillaroscopyis not commonly used.

•       Nailfold capillaroscopy (NFC) is a non-invasive,easy to perform, painless, and sensitive technique for evaluating microvascularinvolvement, mainly in Raynaud’s phenomenon (RP), systemic sclerosis andconnective tissue patients.

•       Moreover, capillaroscopy is now applied topredict the risk of development of future visceral complications and digitalulcers in patients with systemic disease.

•       The nailfold capillary bed is accessible andrevealing capillaries lie parallel to skin allowing the whole capillary loopsto be visualized.

•       Several capillary alterations have beenexplained in diabetes with poor metabolic control. In previous studiescorrelation between the severities of microvasculature changes and metaboliccontrol of diabetes has also been reported.

•       Despite all these findings, little data existon the relationship between microvascular changes in capillaroscopy and type 1,2 diabetes features.

•       Capillaroscopy is a method of recognized valuein the study of morphological and functional abnormalities of themicrocirculation. Its use in the clinical field dates from the early twentiethcentury,1 extending the clinical applications gradually over the years,2,3 tobe considered a “routine investigation†in (nowadays) rheumatological practice.

•       The advantages of capillaroscopy can beidentified in the absence of invasiveness, in its remarkable sensitivity andspecificity together with ease procedure and speed execution time. Therelatively videocapillaroscopy low cost could be considered another bigadvantage of this procedure

•       Microvessel videocapillaroscopy study seems tobe very interesting in diabetes because microangiopathy is the most common andfearsome complication of diabetes and because it seems that the alterations ofcutaneous microvessels and of the fundamental substance of connectiveconstitute the earliest manifestations of the disease.

Research Question

·        What arethe nailfold capillaroscopy findings in patients of diabetes mellitus?

·        Do theycorrelate with presence of retinopathy?

·        Do theycorrelate with Hba1c levels?

·        Do theycorrelate with the duration of the disease?

Aim/Goal

•     Aim: To study the Nailfold Capillaroscopicchanges in patients of Diabetes Mellitus

Objectives: - Ã˜  Primary

Ø  To study the NailfoldCapillaroscopic changes according to the given parameters in patients of DM andreport any new findings if found in the patients.

Ø  Secondary

Ø  To study assosciationbetween diabetic retinopathy and nailfold capillaroscopic changes

Ø  To study assosciationbetween Hba1c levels and NFC changes

Ø  To study assosciationbetween duration of diabetes and of NFC changes

Methodology

Study design/type - This will be anObservational, cross-sectional, comparative study

Studypopulation - â€¢     All newly diagnosed and Established diagnosis of TypeII Diabetes Mellitus according to the criteria of the American DiabetesAssociation, attending dermatology OPD of Sir-T Hospital Bhavnagar.

•     Age & Sex matched controls without any significantcomorbidities will be enrolled accordingly

Samplesize - 122 patients in total–  76 cases and 46 controls.

Studyduration - 10 months

Studysite -

Ø  The study will be conducted in the OPD of

Dermatology,Venereology& Leprosy department at Sir-T

hospital,Bhavnagar.

Study procedures:

 Details of proceduresalong with Inclusion & exclusion criteria

 Details of study groups, intervention, follow up,randomization, blinding, etc - Ã˜  After the patient comes to Opd, diagnosis of DMto be made according to ADA criteraØ  Then the patient will be assessed foreligibility

Ø  Relevant history will be taken and the patients will be subjected torelevant tests like

Ø  Fundoscopic examination

Ø  HbA1c levels

Ø  NFC will be performed when thepatient will come with relevant reports.

Ø  Nailfold capillaroscopy images willbe taken by Firefly 330T dermoscope. Images of all 10 fingers will be includedin the study.

Ø  Procedure will be carried out with the handsplaced at a heart level and in a seated position.

Ø  For the examination of each finger, a drop ofimmersion oil was placed in the nailfold to improve visibility. The capillarieswere observed with a 100x magnification capillaroscope (Firefly 330T) andphotographs 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 diagnosisof Type II Diabetes Mellitus according to the criteria of the American DiabetesAssociation (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 orany cosmetic on the nail.

Ø  Patient suffering from hypertensionor other cardiac co-morbidities

Ø  Preexisting disease that affectsvascular architecture like Raynauds Phenomenon, Systemic Sclerosis, SLE adother connective tissue diseases.

Ø  Patients with a history of Smokingor Trauma in the periungual fold.

Ø  Patients with onychophagia,onychotillomania, with any other nail disease.

Outcomevariables - Capillaroscopic Findings related tomorphology and arrangement of vessles as well as any new parameters will belooked for and its further comparison and correlation will be done (its Dummytables available in ppt). The presence or absence of the following parameterswill be recorded:-

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

•     Neoangiogenesis/bushy capillaries - small, multiplebuds originating from the distal loop

•     Meandering capillaries - limbs crossed upon themselvesseveral times

•     Tortuous capillaries - capillary limb curled but not crossing over

•      Ramifiedcapillaries - they were described as those capillaries that adopt the shapesimilar 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.

•      Dominantmorphology - finding that predominates in more than 20%, whether its open,tortuous or crosslinked.

•     Bizarre Capillaries - atypical morphology notconforming to the predefined morphologies

•      Visibility ofthe subpapillar venous plexus - a network of larger vessels with respect to thecapillaries.

presence of the parameter wasdetermined accordingly.  0: not visible1: doubtful or limited visibility 2: Plexus visible in certain areas 3: Fullyvisible in large areas

•     Cuticulitis - inflammation of the insertion of thecuticle at the periungual fold.

•      SD pattern-  presence of: giant capillaries,avascular zones, haemorrhages and ramified capillaries all together.

•     Receding capillaries - were seen as individualcapillaries maintaining their position in the distal‑most row but presentingslightly proximal to the distal‑most loops

•     Angulated capillaries - were a special type oftortuous capillary where one or both the arms of the distal capillary loop wereseen to bend at an angle

Statistical methods

Data analysisplan:     Type of data, - Ã˜  Studied data will beanalysed and compiled in master chart.

Ø  After tabulation ofdata,statistical analysis will be done.

Ø  The categorical variablewill be analysed by number,percentage,frequency.

Ø  Chi-square will be appliedwherever required.

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