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CTRI Number  CTRI/2020/12/029837 [Registered on: 16/12/2020] Trial Registered Prospectively
Last Modified On: 17/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing nailfold vessel in patients with Type 2 DM 
Scientific Title of Study   “Nailfold Capillaroscopy to assess microcirculation in patients of Diabetes Mellitus, an Observational Study” 
Trial Acronym  NFC-DM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arjun Prakashey 
Designation  Resident 
Affiliation  GMC Bhavnagar 
Address  115, First floor, Skin OPD, Sir T Hospital Campus, near Jail road, Bhavnagar Bhavnagar GUJARAT 364001 India

Bhavnagar
GUJARAT
364001
India 
Phone  09711631900  
Fax    
Email  arjun.24jan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hita Mehta 
Designation  Prof & Head, Dept. of Dermatology 
Affiliation  Govt. Medical College, Bhavnagar 
Address  115, First floor, Skin OPD, Sir T Hospital Campus, near Jail road, Bhavnagar 201 Golden Arc Apartment, Atabhai chowk, Bhavnagar, Gujarat. 364001 Bhavnagar GUJARAT 364001 India

Bhavnagar
GUJARAT
364001
India 
Phone  9429503188  
Fax    
Email  hitamehta88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arjun Prakashey 
Designation  Resident 
Affiliation  GMC Bhavnagar 
Address  115, First floor, Skin OPD, Sir T Hospital Campus, near Jail road, Bhavnagar Bhavnagar GUJARAT 364001 India

Bhavnagar
GUJARAT
364001
India 
Phone  09711631900  
Fax    
Email  arjun.24jan@gmail.com  
 
Source of Monetary or Material Support  
Dr Arjun Prakashey - Sir-T Hospital, Bhavnagar 
 
Primary Sponsor  
Name  Dr Arjun Prakashey 
Address  203, PG-2 Hostel, Sir-T Hospital, Bhavnagar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun Prakashey  Sir-T Hospital, Bhavnagar  115, First floor, Skin OPD, Sir T Hospital Campus, near Jail road, Bhavnagar Bhavnagar GUJARAT 364001 India
Bhavnagar
GUJARAT 
9711631900

arjun.24jan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, Government Medical College, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All newly diagnosed and Established diagnosis of Type II Diabetes Mellitus according to the criteria of the American Diabetes Association (ADA)(2).
Age group 20-60 years
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Changes if nailfold capillaries will be observed via capillaroscope in diabetic patients and will be seen according to the following parameters

Dilated/Giant capillaries
Neoangiogenesis/bushy capillaries -
Meandering capillaries -
Tortuous capillaries - Ramified capillaries - Avascular zones -
Haemorrhages -
Dominant morphology -
Bizarre Capillaries -
Visibility of the subpapillar venous plexus - Cuticulitis
SD pattern
Receding capillaries
Angulated capillaries
 
Changes if nailfold capillaries will be observed via capillaroscope in diabetic patients and will be seen at Baseline, i.e when patient comes at the first visit itself. 
 
Secondary Outcome  
Outcome  TimePoints 
To study assosciation between diabetic retinopathy and nailfold capillaroscopic changes
To study assosciation between Hba1c levels and NFC changes
To study assosciation between duration of diabetes and of NFC changes
 
Comparison will be done after the initial evaluation 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   17/12/2020 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title of the Project/Thesis/Dissertation:

“Nailfold Capillaroscopy to assess microcirculation in patients of Diabetes Mellitus, an Observational Study”


Introduction

•       Diabetes is currently considered a chronic disease with a high mortality rate due to its longterm cardiovascular and renal complications.

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

•       The current trend for evaluating microvascular damage in diabetic patients is the use of: Doppler flowmetry, direct and indirect ophthalmoscopy, ambulatory blood pressure monitoring, but capillaroscopy is not commonly used.

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

•       Moreover, capillaroscopy is now applied to predict the risk of development of future visceral complications and digital ulcers in patients with systemic disease.

•       The nailfold capillary bed is accessible and revealing capillaries lie parallel to skin allowing the whole capillary loops to be visualized.

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

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

•       Capillaroscopy is a method of recognized value in the study of morphological and functional abnormalities of the microcirculation. Its use in the clinical field dates from the early twentieth century,1 extending the clinical applications gradually over the years,2,3 to be considered a “routine investigation” in (nowadays) rheumatological practice.

•       The advantages of capillaroscopy can be identified in the absence of invasiveness, in its remarkable sensitivity and specificity together with ease procedure and speed execution time. The relatively videocapillaroscopy low cost could be considered another big advantage of this procedure

•       Microvessel videocapillaroscopy study seems to be very interesting in diabetes because microangiopathy is the most common and fearsome complication of diabetes and because it seems that the alterations of cutaneous microvessels and of the fundamental substance of connective constitute the earliest manifestations of the disease. 

Research Question

·         What are the nailfold capillaroscopy findings in patients of diabetes mellitus?

·         Do they correlate with presence of retinopathy?

·         Do they correlate with Hba1c levels?

·         Do they correlate with the duration of the disease?


Aim/Goal

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

Objectives: - Ã˜  Primary

Ø  To study the Nailfold Capillaroscopic changes according to the given parameters in patients of DM and report any new findings if found in the patients.

Ø  Secondary

Ø  To study assosciation between diabetic retinopathy and nailfold capillaroscopic changes

Ø  To study assosciation between Hba1c levels and NFC changes

Ø  To study assosciation between duration of diabetes and of NFC changes

Methodology

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

Study population - â€¢      All newly diagnosed and Established diagnosis of Type II Diabetes Mellitus according to the criteria of the American Diabetes Association, attending dermatology OPD of Sir-T Hospital Bhavnagar.

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

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

Study duration - 10 months

Study site -

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 - Ã˜  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, - Ã˜  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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