| CTRI Number |
CTRI/2025/12/099690 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Pilot study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a New Imaging device to Check Blood Flow in Burn Wounds and Predict How Fast They Will Heal |
|
Scientific Title of Study
|
A Pilot Prospective Observational Study to Evaluate the Utility of Laser Speckle Contrast Imaging (LSCI) using Angiocam (Ayati Devices, India) for Perfusion Assessment in Partial-Thickness Burn Wounds to Aid Burn Depth Estimation and Healing Prediction |
| Trial Acronym |
ANGIO-HEAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room no 202 2nd Floor Burns and Surgery Block, Department of Plastic Reconstructive and Burns Surgery
New Delhi
DELHI
110029
India |
| Phone |
9810373345 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room no 202 2nd Floor Burns and Surgery Block, Department of Plastic Reconstructive and Burns Surgery
DELHI
110029
India |
| Phone |
9810373345 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room no 202 2nd Floor Burns and Surgery Block, Department of Plastic Reconstructive and Burns Surgery
DELHI
110029
India |
| Phone |
9810373345 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayati Devices Private Limited 1071 11th Main Rd Appareddipalya Indiranagar Bengaluru Karnataka Pincode 560008 Country India |
|
|
Primary Sponsor
|
| Name |
Ayati Devices Pvt Ltd |
| Address |
BLOCK A, 2nd Floor, DERBI Foundation, Dayanand Sagar University, Kudlu gate, Bangalore 560068 |
| Type of Sponsor |
Other [Private Limited Company ] |
|
|
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 Maneesh Singhal |
All India Institute of Medical Sciences, New Delhi |
Emergency and ward 3rd and 4th Floor of Department of Plastic Reconstructive and Burns Surgery
New Delhi
DELHI |
9810373345
drmaneesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee All India Institute of Medical Sciences New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T241||Burn of first degree of lower limb, except ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 18 year to 60 years
2. Presention of the burn wound through the device first 96 hours of admission
3. Total Burn surface area should be less than 20 percent |
|
| ExclusionCriteria |
| Details |
1. Burns on palms, soles, or face due to high baseline perfusion variability.
2. Wounds already covered with biological/xenograft/synthetic dressings.
3. Patients unable or unwilling to undergo imaging
4. Known photosensitive disorders or use of photosensitizing drugs.
5. Concurrent participation in another study affecting wound healing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To check re-epithelialize, remains unhealed, or required surgical intervention.
2. |
Day 1 and 21th days of 3rd week of follow up of patient in the hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/01/2026 |
| 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
|
The purpose of this pilot study is to generate preliminary clinical evidence on the feasibility and utility of Angiocam - an indigenous Laser Speckle Contrast Imaging (LSCI) system - for assessing microvascular perfusion in partial-thickness burn wounds. By quantifying perfusion patterns early after injury, the study aims to explore the potential of LSCI-based imaging to assist clinicians in estimating burn depth and predicting healing time. Insights from this pilot will help optimize imaging protocols and guide the design of subsequent larger validation studies. |