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CTRI Number  CTRI/2024/12/077527 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Educational]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of an Interprofessional Education (IPE) Module on Improving Foot Care in Patients with Type 2 Diabetes Mellitus 
Scientific Title of Study   Influence of Interprofessional Educational (IPE) Module for Enhancing Foot Care among Individuals 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 Bhukya Nom Kumar Naik 
Designation  PhD Research Scholar 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9121346449  
Fax    
Email  bhukyanomnaik61@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SUSHMA PRABHATH 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  9880895097  
Fax    
Email  sushma.rk@Manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bhukya Nom Kumar Naik 
Designation  PhD Research Scholar 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9121346449  
Fax    
Email  bhukyanomnaik61@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Dr Bhukya Nom Kumar Naik 
Address  Department of Anatomy, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India 
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 Bhukya Nom Kumar Naik  Kasturba Hospital Manipal  Department of Medicine, Department of Endocrinology, Centre for Diabetic Foot Care Research (CDFCR)
Udupi
KARNATAKA 		 9121346449

bhukyanomnaik61@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Interprofessional Education (IPE) intervention  10 - 15 hours of IPE intervention for a period of 30 Days 
Comparator Agent  No IPE (Interprofessional Education) Intervention  0 days IPE Intervention.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adults aged 18–80 with Type 2 Diabetes Mellitus (T2DM).
2. The individuals who will give consent.
3. Individuals who have had T2DM for at least 6 months.
4. Those with the ability to provide self care.
5. Diabetic individuals with different glycemic levels (HbA1c) or Increased RBS levels (As per WHO references)
6. Individuals with a high risk of developing DFU (Known cases of diabetic neuropathy, Diabetic Ischemia, and both Diabetic Neuropathy and ischemia)
7. Individuals with the ability to understand and communicate in either the Kannada or English language.
8. Participants are comfortable using social media tools like WhatsApp or other social media tools.
 
 
ExclusionCriteria 
Details  1. Adults diagnosed with Type – 1 Diabetes, impaired fasting glucose, impaired glucose tolerance,
2. Gestational diabetes (Altered Insulin Production).
3. Patients with Recent or heavy blood loss.
4. Patients who developed foot ulcers or with any other form of foot deformity.
5. Individuals with a cognitive/speech impairment.
6. Those with an attention deficit.
7. Individuals facing mental challenges or disabilities.
8. Those with physical challenges or disabilities.
9. Individuals with an inability to mobilize 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Enhancing in glycemic parameters (HbA1C or RBS).
Enhancement in diabetic foot care practices through interprofessional education.
Decrease in diabetic foot complications.
Enhanced Diabetic foot self-reported practices
 		 Baseline, 4th week, 3rd Month and 6th Month 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not applicable 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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)   11/11/2025 
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="2"
Months="6"
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  

Summary of the Study with 6 Steps

  1. Enrolment: Participants are enrolled using strict inclusion/exclusion criteria. Demographic data is collected, and a pre-test is conducted to assess knowledge and practices related to diabetic foot self-management.

  2. Allocation: Participants are randomly assigned to an Interventional Group or Control Group using a coin-toss method. The study is conducted across various healthcare settings like endocrinology, surgery, and physiotherapy.

  3. Intervention: The Interventional Group receives a structured intervention as proposed outlined in Protocol submitted to IEC.

  4. Follow-up: The researcher coordinates with healthcare professionals to address issues and maintains regular communication with participants for six months.

  5. Data Collection: Data is gathered pre- and post-intervention, including knowledge and practice scores, glycaemic values (HbA1c and RBS), and foot assessments from CDFCR. Financial support is provided to economically constrained participants.

  6. Analysis: Statistical analysis is performed using paired t-tests with software like SPSS V27 or Jamovi to evaluate the module’s impact on knowledge, behavior, and clinical outcomes. Findings will be published.

 
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