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CTRI Number  CTRI/2020/02/023635 [Registered on: 27/02/2020] Trial Registered Prospectively
Last Modified On: 26/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of foot of diabetic patients to screen risk of diabetic foot ulcer. 
Scientific Title of Study   A prospective study of evaluating foot in diabetes and distributing the components of evaluation through Amit Jains Triple Assessment for foot. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrilaxmi R 
Designation  Post Graduate Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital. 
Address  Department of PG Studies in Shalya tantra, Sri Sri College of Ayurvedic Science and Research Hospital.

Bangalore Rural
KARNATAKA
560082
India 
Phone  8762535733  
Fax    
Email  shrikinnigoli058@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prem Chandra  
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital. 
Address  Department of PG Studies in Shalya tantra, Sri Sri College of Ayurvedic Science and Research Hospital.

Bangalore Rural
KARNATAKA
560082
India 
Phone  9980691111  
Fax    
Email  drpremms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prem Chandra  
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital. 
Address  Department of PG Studies in Shalya tantra, Sri Sri College of Ayurvedic Science and Research Hospital.

Bangalore Rural
KARNATAKA
560082
India 
Phone  9980691111  
Fax    
Email  drpremms@gmail.com  
 
Source of Monetary or Material Support  
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 
 
Primary Sponsor  
Name  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st KM, Kanakapura road, Bengaluru, Karnataka. 
Type of Sponsor  Private medical college 
 
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 Shrilaxmi R  Sri Sri College of Ayurvedic Science and Research Hospital  Department of PG Studies in Shalya tantra, Sri Sri College of Ayurvedic Science and Research Hospital.
Bangalore Rural
KARNATAKA 		 8762535733

shrikinnigoli058@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE, BENGALURU 560082  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects suffering from diabetes mellitus.
2.Subjects of both genders.
3.Age of the Subjects from 30 to 70yrs
 
 
ExclusionCriteria 
Details  1. Subjects with past history of major surgeries like debridement and skin grafting of the foot.
2. Subjects with a history of trauma, burns, malignancy, tubercular ulcers, amputated leg.
3.Immunocompromised subjects like HIV positive cases, subjects on long term steroid therapy, etc.
4. HBsAg positive subjects
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early detection of diabetic foot ulcer  5 Minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Screening for risk of diabetic foot ulcer  5 Minutes 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/03/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Diabetic foot is a spectrum of foot disorders ranging from ulceration and gangrene occurring in diabetics as a result of peripheral neuropathy or ischemia or infection. Diabetic foot ulcers affect 15%–25% of people during their lifetime. The ulcers are prone to infections, chronicity, and recurrences, and between 5%–24% of them may result in limb amputation. Despite the knowledge of the consequences of diabetic foot, foot evaluation is often neglected in clinical practice. The diabetic foot has become a devastating complication of diabetes. Diabetic foot screening is known to be a cornerstone and starting point of all good diabetic foot care. Although various screening methods exist for diabetic foot, they are difficult to be remembered and often require a chart for recording. Amit Jain’s Triple Assessment for the diabetic foot is very simple, easy to remember and practical. Further, it can be applied with ease by different specialists and health care professionals in different parts of the world without requiring advanced training. Thereby screening of the diabetic foot will help in identifying any underlying problems and helps one to immediately institute preventive and therapeutic measures.     
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