| 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
|
|
|
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
|
|
|
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. |