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CTRI Number  CTRI/2025/12/099230 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How work related factors affect the risk of Diabetic Foot problems in Coastal Karnataka. 
Scientific Title of Study   Investigation of occupational risk factors contributing to Diabetic Foot Syndrome (DFS) in Coastal Karnataka. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Utkarsh Sinha 
Designation  Undergraduate (MBBS PY 3.2) 
Affiliation  Kasturba Medical College, Manipal  
Address  Kasturba Medical College, MAHE- University, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8073602253  
Fax    
Email  utkarsh.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhila D 
Designation  Assistant Professor  
Affiliation  Kasturba Medical College, Manipal  
Address  Department of Community Medicine, Kasturba Medical College, MAHE- University, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9663703716  
Fax    
Email  akhila.d@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Utkarsh Sinha 
Designation  Undergraduate (MBBS PY 3.2) 
Affiliation  Kasturba Medical College, Manipal  
Address  Kasturba Medical College, MAHE- University, Madhav Nagar, Manipal


KARNATAKA
576104
India 
Phone  8073602253  
Fax    
Email  utkarsh.kmcmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) Short Term Studentship (STS)  
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) Short Term Studentship (STS)  
Address  Division of Human Resource Development (HRD), Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
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 Akhila D  Kasturba Hospital, Manipal  Department of Community Medicine, Kasturba Medical College, MAHE University, Manipal- 576104
Udupi
KARNATAKA 		 9663703716

akhila.d@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients suffering from Type 2 Diabetes Mellitus irrespective of duration of disease who have an associated foot ulcer. 
 
ExclusionCriteria 
Details  Patients suffering from Diabetes Mellitus other than Type 2.
Patients who have varicose ulcers.
Patients suffering from polyneuropathy excluding Diabetes Mellitus.
Patients who are unable to communicate
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between occupational/workplace related factors and the presence/severity of Diabetic Foot Syndrome (DFS).  Assessed once at the time of recruitment. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess activities of Daily Living among patients with DFS undergoing treatment.  Assessed once at the time of recruitment. 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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)   29/12/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study aims to investigate how different occupations and workplace related conditions contribute to the development and severity of Diabetic Foot Syndrome (DFS) among individuals with Type 2 Diabetes Mellitus in Coastal Karnataka. DFS is a major cause of disability, hospitalization, and amputation, and early identification of modifiable risk factors is essential for prevention. The study will use a cross-sectional design to collect data on socio-demographic characteristics, occupational activities, workplace hygiene and safety, physical activity levels, and DFS severity at a single point in time. By analyzing these variables, the study seeks to identify specific occupational categories and working environments that place diabetic individuals at higher risk of developing foot complications. The central hypothesis is that certain occupational factors such as prolonged standing, physically strenuous work, inadequate footwear, poor workplace hygiene, or limited access to timely medical care are significantly associated with an increased likelihood and severity of DFS. Insights from this research may help guide preventive strategies, workplace modifications, and public health initiatives aimed at reducing DFS-related morbidity. 
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