| CTRI Number |
CTRI/2026/02/104960 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Smart Footwear intervention for the prevention of Diabetic foot ulcer |
|
Scientific Title of Study
|
Smart Bio-Sensor footwear, a unique device combining multi-sensor, AI-driven healing interventions for the prevention of Diabetic foot Ulcer |
| 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 Keval Dhone |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Room number 202, Department of General Surgery, All India Institute of Medical Sciences, MIHAN, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9763258898 |
| Fax |
|
| Email |
kewaldhone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unnati Shirbhate |
| Designation |
Research Scientist |
| Affiliation |
AIIMS Nagpur |
| Address |
Room number 202, Department of General Surgery, All India Institute of Medical Sciences, MIHAN, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7020106697 |
| Fax |
|
| Email |
unnatishirbhate0791@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Unnati Shirbhate |
| Designation |
Research Scientist |
| Affiliation |
AIIMS Nagpur |
| Address |
Room number 202, Department of General Surgery, All India Institute of Medical Sciences, MIHAN, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7020106697 |
| Fax |
|
| Email |
unnatishirbhate0791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
ICMR Headquarters, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Nagpur |
All India Institute of Medical Sciences, MIHAN, Nagpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keval Dhone |
AIIMS, Nagpur |
Room number 202, Department of General Surgery, All India Institute of Medical Sciences, Nagpur
Nagpur
MAHARASHTRA |
9763258898
kewaldhone@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Smart Biosensor Footwear |
The device records pressure, temperature, moisture and sweat glucose levels continuously (12 hours/day during use), with automated data logging at predefined intervals. Monitoring will be conducted throughout the 3-month study period, with clinical assessments at baseline, 1 and 3 months. |
| Comparator Agent |
Standard manual measures |
Manual measurement of pressure, temperature, moisture, and glucose will be done at baseline, 1 month and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients at risk for pressure ulcers/diabetic foot ulcers
Age more than 18 years
No active ulcer at baseline |
|
| ExclusionCriteria |
| Details |
Active ulcer at enrolment
Severe comorbid conditions affecting skin integrity
Patients not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Diabetic Foot Ulcer occurrence |
Outcome will be monitored throughout the 3-month study period, with clinical assessments at baseline, 1 and 3 months. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="432"
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)
|
20/03/2026 |
| 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="2"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
By
combining novel sensor technologies, AI analytics, and therapeutic
interventions, this study will generate groundbreaking IP that can
revolutionize DFU prevention and set new standards in wearable healthcare technologies. The resulting patents,
copyrights, and proprietary methodologies will ensure long-term competitive
advantages and create opportunities for global impact. |