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CTRI Number  CTRI/2025/03/083253 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A novel mobile application to ensure proper diabetic foot ulcer care with wound photographs and chat based communication 
Scientific Title of Study   Development of a novel mobile based smartphone application ensuring proper diabetic foot ulcer care using regular wound photographs, videos and chat based communication in diabetic foot ulcer patients to prevent complications. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranay B R 
Designation  Post graduate 
Affiliation  Saveetha Medical College and Hospital 
Address  Room No 201, 2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9962386757  
Fax    
Email  pranaybazaar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagarajan D 
Designation  Professor, General Surgery 
Affiliation  Saveetha Medical College and Hospital 
Address  Room No 201, 2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam Chennai
Room No 201, 2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam Chennai
Chennai
TAMIL NADU
602105
India 
Phone  9444070583  
Fax    
Email  drnagarajmmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pranay B R 
Designation  Post graduate 
Affiliation  Saveetha Medical College and Hospital 
Address  Room No 201, 2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9962386757  
Fax    
Email  pranaybazaar@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 
 
Primary Sponsor  
Name  Dr Pranay B R 
Address  Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 
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 Pranay B R  Saveetha Medical College Hospital  Room no 201, Department of General Surgery, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai- 602105
Chennai
TAMIL NADU 
9962386757

pranaybazaar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College And 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: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with diabetic foot ulcers who are willing to undergo the study.  
 
ExclusionCriteria 
Details  Patients who are not willing to undergo the study. Non diabetic patients. Vascular or neurological ulcers  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Effective and efficient way to ensure diabetic foot ulcer care and preventing all complications of Diabetic foot ulcers in patients using the mobile application.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Improving the awareness of diabetic foot ulcers and ensuring proper care for those affected in the community  13 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
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  

The "Integrated Diabetic Foot Ulcer Care" application is a comprehensive solution designed to address the needs of patients suffering from diabetic foot ulcers (DFUs). It combines healthcare and technology to offer a range of features aimed at improving patient outcomes and preventing complications associated with DFUs.

Key features of the application include:

1. Remote Monitoring: Patients can upload daily photographs of their foot ulcers, allowing healthcare professionals to monitor wound progression and provide timely interventions.

2. Communication Platform: The app facilitates communication between doctors and patients through chat-based consultations, enabling users to seek guidance and clarification on wound care techniques.

3. Educational Resources: The application provides instructional videos on proper dressing techniques and offers guidance on diabetic diet and blood glucose monitoring, empowering patients with knowledge to manage their condition effectively.

4. User-Friendly Interface: Designed for ease of use, the application allows seamless uploading of videos, photographs, and blood reports, ensuring accessibility for patients with varying levels of technological proficiency.

Overall, the "Integrated Diabetic Foot Ulcer Care" application aims to bridge the gap between healthcare providers and patients, facilitating continuous care and support for individuals with DFUs to prevent complications and improve treatment outcomes.

 
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