| 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
|
|
|
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
|
|
|
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. |