FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090097 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   A new strategy for identifying early signs of foot problems in people with high blood sugar to prevent future foot complications 
Scientific Title of Study   Novel approach for early screening and prevention of foot complications in T2 Diabetes Mellitus at rural community level of coastal districts; Manipal Amputation Prevention Program among People Living with Type 2 Diabetes Mellitus  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Arun Maiya 
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE Manipal 
Address  Room No.1 Centre for podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya 
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE Manipal 
Address  Room No.1 Centre for podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Arun Maiya 
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE Manipal 
Address  Room No.1 Centre for podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
RailTel Corporation of India Ltd, Plate-A, 6th floor, Office block tower 2, East Kidwai Nagar, New Delhi- 110023  
 
Primary Sponsor  
Name  RailTel Corporation of India Ltd 
Address  RailTel Corporation of India Ltd Plate-A, 6th floor, Office block tower 2, East Kidwai Nagar, New Delhi- 110023 
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 G Arun Maiya  Kasturba Hospital, Manipal  Room number 1, ground floor, Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy,Manipal, Karnataka, India
Udupi
KARNATAKA 		 9845350823

arun.maiya@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  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 
Comparator Agent  NIL  NIL No comparator agent 
Intervention  Training of health professions  Training will cover diabetic foot care, footwear selection, and patient communication, supplemented by workshops, hands-on training, and screening forms. We will be assessing the pre and post knowledge of the health professionals using questionnaire. Total duration of intervention is 3 months 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Inclusion criteria for healthcare professionals:
1.1. Individuals who are doctors, nurses, public health professionals, physiotherapists, and ASHA workers
1.2. Healthcare professionals of any age
1.3. Individuals who are working in healthcare setups in Udupi district

2. Inclusion criteria for the general population:
2.1. People of the Udupi district
2.2. Individuals more than 45 years of age
2.3. People with or without diabetes

3. Inclusion criteria for patients with type 2 diabetes mellitus:
3.1. Individuals who are more than 45 years of age
3.2. Individuals with pre-diabetes and diabetes 
 
ExclusionCriteria 
Details  1. Exclusion criteria for healthcare professionals:
1.1. Healthcare professionals are not willing to participate due to inadequate availability
1.2. Short-term visiting healthcare professionals from outside the Udupi district

2. Exclusion criteria for the general population:
2.1. People from outside the Udupi district

3. Exclusion criteria for patients with type 2 diabetes mellitus:
3.1. People with locomotory dysfunction
3.2. Psychiatric dysfunction
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
For the primary objective, the training of healthcare professionals, outcomes include questionnaire.

For the secondary objective, the screening of type 2 diabetes mellitus patients, outcome measures will be used
Neuropathic assessments:
- Monofilament testing
- Vibration perception threshold
Vascular assessments:
- Thermometry (using IR thermometer)
- Ankle Brachial Index (ABI)
Musculoskeletal assessment:
- muscle strength
- muscle tightness 		 The questionnaire will be administered prior to training session and post training session.

For screening, all outcome measures are conducted or used at one time point at baseline during screening. 
 
Secondary Outcome  
Outcome  TimePoints 
Plantar pressure assessment using the Harris mat
Footwear assessments 		 Plantar pressure assessment & footwear assessments will be conducted at two time points one at baseline & after 3months 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   18/07/2025 
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="0"
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 interventional study aims to reduce foot complications in people with type 2 diabetes mellitus living in rural coastal areas by focusing on early screening, prevention, and education. The objective of the study includes 1. training the health professionals in screening, identification, and management of diabetic foot complications 2. Screen individuals with diabetes for foot complications and provide customized insoles for abnormal plantar pressure with footwear prescriptions 3. Promote awareness about diabetes, its complications, prevention, and management among the general population and those at risk of developing diabetes. 

• In this study, we will train health professionals to screen, identify, and manage diabetic foot complications and to educate patients and their caregivers. Training will cover diabetic foot care, footwear selection, and patient communication, supplemented by workshops, hands-on training, and screening forms. 
• Awareness initiatives will be conducted in the community, utilizing pamphlets, booklets, and awareness camps about diabetes, its complications, and prevention strategies.
• A comprehensive screening procedure will assess neuropathic status (vibration perception threshold and monofilament testing), vascular status (pedal pulsation, ankle–brachial index, and thermometry using an IR thermometer), and musculoskeletal parameters (muscle strength and tightness).
• Those identified with foot complications will undergo plantar pressure assessments and digital foot scanning to customize insoles and footwear. These custom orthotics will be tailored to patient-specific pressure points and foot morphology to reduce the risk of foot ulcers and amputation.

A minimum of 100 healthcare professionals will be trained for the first objective, around 2,000 participants with type 2 diabetes mellitus will be recruited from rural coastal communities for diabetic foot screening, and a minimum of 10 awareness camps will be held. Statistical analyses will be performed using Jamovi software, presenting demographic data as mean and standard deviation and frequency analysis for descriptive statistics.
 
Close