| CTRI Number |
CTRI/2025/09/095125 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Design and development of an automated smart bed for pressure sore prevention and management. |
|
Scientific Title of Study
|
Smart sensor-based responsive mattress for offloading and treating pressure sores. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joseph Thomas |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Plastic Surgery, Kasturba Medical College and Hospital,
Manipal Academy of Higher Education,
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9995783582 |
| Fax |
|
| Email |
joseph.plastic@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseph Thomas |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Plastic Surgery, Kasturba Medical College and Hospital,
Manipal Academy of Higher Education,
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9995783582 |
| Fax |
|
| Email |
joseph.plastic@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joseph Thomas |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Plastic Surgery, Kasturba Medical College and Hospital,
Manipal Academy of Higher Education,
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9995783582 |
| Fax |
|
| Email |
joseph.plastic@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, Post box 4911, New Delhi - 110029, India. |
|
|
Primary Sponsor
|
| Name |
Dr Joseph Thomas |
| Address |
Department of Plastic Surgery, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal - 576104 Karnataka, India. |
| Type of Sponsor |
Private medical college |
|
|
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 Joseph Thomas |
Kasturba Hospital |
Department of Plastic Surgery, Kasturba Hospital, Manipal Academy of Higher Education, Manipal-576104.
Udupi
KARNATAKA |
9995783582
joseph.plastic@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pressure Ulcers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pixelated smart mattress with remote control |
The smart sensor based mattress will be developed and tested in healthy volunteers for 6-10 iterations. These trials will be conducted at an approximate period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy ambulant volunteers |
|
| ExclusionCriteria |
| Details |
1. Persons disabilities or disorders affecting mobility.
2. Paraplegics/ quadriplegics
3. Persons suffering from decreased sensations anywhere on the body
4. Persons with wounds
5. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure, stretch, moisture, and temperature readings from the patient and device sensors will be recorded, and the difference in readings with the actuation of the device will be evaluated, and iterative development of the device will be carried out based on them. |
1. Year 2 - Five live healthy subjects will be involved for 6 trial iterations.
2. Year 3 – Five live healthy subjects will be involved for 4 trial iterations. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
06/11/2026 |
| 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="3"
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
|
This is a prospective intervention trial with the hypothesis that a pixelated smart grid mattress enabled with small and large displacements for preventing the occurrence of pressure sores in bedridden patients. A prototype bed will be developed and tested and validated on healthy volunteers. The expected outcome is the demonstration of smart pixellated mattress/cushion which is programmable to offload the body at specific areas for the prevention of pressure ulcers and evaluate its performance through defined parameters. |