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CTRI Number  CTRI/2026/02/103577 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   AI enabled mobile application for wound image assessment in ulcer patients 
Scientific Title of Study   Novel technology for clinical validation of an Artificial intelligence enabled wound imaging mobile application in Ulcers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nihiladhithya 
Designation  MBBS MS Post graduate 
Affiliation  Saveetha medical college and hospital 
Address  451 Irulapalayam Road Opposite EVP Theme Park Off NH4 Kuthambakkam Tamil Nadu 600124.

Kancheepuram
TAMIL NADU
600124
India 
Phone  9003325250  
Fax    
Email  naveen.nihil20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nihiladhithya 
Designation  MBBS MS Post graduate 
Affiliation  Saveetha medical college and hospital 
Address  451 Irulapalayam Road Opposite EVP Theme Park Off NH4 Kuthambakkam Tamil Nadu 600124.


TAMIL NADU
600124
India 
Phone  9003325250  
Fax    
Email  naveen.nihil20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nihiladhithya 
Designation  MBBS MS Post graduate 
Affiliation  Saveetha medical college and hospital 
Address  451 Irulapalayam Road Opposite EVP Theme Park Off NH4 Kuthambakkam Tamil Nadu 600124.


TAMIL NADU
600124
India 
Phone  9003325250  
Fax    
Email  naveen.nihil20@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College And Hospital Thandalam Chennai 602105 Tamil Nadu India 
 
Primary Sponsor  
Name  Saveetha medical college and hospital 
Address  Saveetha Medical College And Hospital Thandalam Chennai 602105 Tamil Nadu India 
Type of Sponsor  Other [Academic institution] 
 
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 Praveen  Saveetha medical college and hospital  162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105.
Kancheepuram
TAMIL NADU 
8870767161

Sppraveen666@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: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AI-enabled wound imaging mobile application (WOUND-AI)  Use of an artificial intelligence–enabled wound imaging mobile application for non-invasive capture and analysis of ulcer photographs for measurement and assessment purposes only. No therapeutic or management intervention is introduced, and standard clinical care is not altered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult patients more than or equal to 18 years with clinically diagnosed ulcers diabetic foot ulcers venous ulcers or pressure ulcers who provide informed consent and whose wounds are suitable for photographic documentation. 
 
ExclusionCriteria 
Details  Patients with malignant ulcers, wounds not suitable for photographic capture, patients unwilling to provide informed consent, or those with severe systemic illness precluding participation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agreement between AI generated wound tissue classification and wound dimension estimation and clinician gold-standard assessments.  At the time of image capture during baseline and follow up visits. 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility and usability of the AI-enabled wound imaging application in clinical use.  Throughout study period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/02/2026 
Date of Study Completion (India) 31/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2026 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

This is a single-arm prospective diagnostic accuracy study designed to clinically validate an artificial intelligence–enabled wound imaging mobile application for the classification of chronic ulcers as healing or non-healing. The application uses a convolutional neural network trained on annotated wound images to extract visual features including colour distribution, surface texture, and tissue morphology, and generates a binary classification output — healing or non-healing — accompanied by a confidence percentage score. The model does not perform geometric wound measurement or tissue segmentation. For each enrolled patient, the examining clinician first records a structured assessment of wound status using pre-defined criteria based on wound size trajectory, granulation tissue quality, infection status, and wound bed appearance. This clinician assessment serves as the reference standard. A standardized wound photograph is then captured using the AI application, which generates its classification independently. Both outputs are recorded separately. The primary objective is to determine the sensitivity, specificity, positive predictive value, negative predictive value, overall accuracy, and Cohen’s kappa of the application against the clinician reference standard. Receiver operating characteristic curve analysis will be performed using the confidence percentage score as a continuous variable to compute the area under the curve. The study population consists of adult patients aged 18 years and above with clinically diagnosed chronic ulcers including diabetic foot ulcers, venous ulcers, and pressure ulcers, presenting to the Department of General Surgery, Saveetha Medical College and Hospital, Chennai. Target sample size is 120 patients. The study is registered prospectively and has received Institutional Ethics Committee approval. No therapeutic intervention is involved. Standard clinical care is not altered by participation.

 
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