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CTRI Number  CTRI/2025/07/091218 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational sessions on foot care]  
Study Design  Other 
Public Title of Study   A study to assess the effect of nurse led interventions on attitude and practices of diabetic patients towards foot care practices. 
Scientific Title of Study   Effect of Nurse Led intervention regarding prevention of diabetic foot ulcers on attitude, practices and clinical outcomes among high-risk Non-Insulin Dependent Diabetes Mellitus (NIDDM) patients in Delhi/NCR: A mixed method study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanika Rai 
Designation  Professor 
Affiliation  Chitkara University, Rajpura, Punjab 
Address  School of Health Sciences, Department of Nursing, Chitkara University, Rajpura, Punjab

Patiala
PUNJAB
140401
India 
Phone  9872820564  
Fax    
Email  kanika@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Farrha Khan 
Designation  PhD Nursing Scholar 
Affiliation  CHITKARA UNIVERSITY RAJPURA PUNJAB 
Address  Department of Nursing, School of health sciences, Chitkara University, Rajpura, Punjab

Patiala
PUNJAB
140401
India 
Phone  9717157001  
Fax    
Email  farrha02@gmail.com  
 
Details of Contact Person
Public Query  
Name  FARRHA KHAN 
Designation  PhD Nursing Scholar 
Affiliation  CHITKARA UNIVERSITY RAJPURA PUNJAB 
Address  Department of Nursing, School of Health Sciences, Chitkara University, Rajpura, Punjab

Patiala
PUNJAB
140401
India 
Phone  9717157001  
Fax    
Email  farrha02@gmail.com  
 
Source of Monetary or Material Support  
E.S.I.C. Hospital and Medical College, Noida, U.P. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [No funding taken from any 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 Tanveer Karim  ESIC HOSPITAL AND MEDICAL COLLEGE NOIDA  ESIC HOSPITAL AND MEDICAL COLLEGE, SECTOR-24, NOIDA
Gautam Buddha Nagar
UTTAR PRADESH 		 9871276888

ms-noida@esic.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC ESIC  Approved 
IHEC CHITKARA UNIVERSITY PUNJAB  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  Nurse led Interventions  Nurse led interventions include one to one educational sessions on foot care, provide informational video on foot care and a booklet to read on prevention of diabetic foot ulcers and foot care. Total duration of educational sessions will be one week then post test will be conducted on 6th and 12th week.  
Comparator Agent  Routine Care  Patient will receive standard care as per policies and services of the hospital. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  NIDDM patients attending OPD and who are willing to participate in the study and will be able to complete the study are going to be included in the study. 
 
ExclusionCriteria 
Details  Patients with diabetic nephropathy and diabetic retinopathy and pregnant patient will not be included in the study. Patient who do not read and understand Hindi or English language will not be included in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The educational interventions will bring positive changes in the attitude of NIDDM patients regarding foot care and improve their foot care practices  Post test will be conducted on 6th week and 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   01/08/2025 
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="0"
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   This study aims to evaluate the effect of nurse led interventions on the prevention of diabetic foot ulcers among high risk non insulin dependent diabetes mellitus patients in Delhi/NCR. It uses a mixed method design (Explanatory sequential research design). The quantitative phase includes assessment of risk, attitude, practices, and clinical outcomes before and after the intervention among experimental and control groups. The qualitative phase explores the experiences and perceptions of patients regarding foot care and nurse led interventions. The intervention includes structured education sessions, telephonic follow up, and foot care demonstrations. The expected outcome is improved knowledge, positive attitude, better foot care practices, and improved clinical parameters among patients. The study will contribute to evidence based nursing strategies to reduce diabetic foot complications. 
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