| CTRI Number |
CTRI/2025/10/096201 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of an Innovative Device for Detecting Pressure Point Sensation and Vibration Perception Loss in Patients with Diabetes |
|
Scientific Title of Study
|
Innovative Device for Pressure Point Identification and Vibration Perception Assessment in Diabetic Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purushothaman D |
| Designation |
Post Graduate, General surgery |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General surgery, Saveetha Medical College and Hospitals,Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9677012723 |
| Fax |
|
| Email |
purushoth678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Muthukumaran G |
| Designation |
Professor of General Surgery |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General Surgery, Saveetha Medical College and Hospitals,thandalam,chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9840170308 |
| Fax |
|
| Email |
gmkumaran99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purushothaman D |
| Designation |
Post Graduate, General Surgery |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General Surgery, Saveetha Medical College, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9677012723 |
| Fax |
|
| Email |
purushoth678@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital,Saveetha nagar,Thandalam,Chennai-602015 |
|
|
Primary Sponsor
|
| Name |
D.Purushothaman |
| Address |
Saveetha Medical College and Hospital,Saveetha nagar,Thandalam,Chennai-602015 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DPurushothaman |
Saveetha Medical College and Hospital |
2nd floor,Department of General Surgery,Saveetha Medical College and Hospital,Saveetha nagar,Thandalam,Chennai-602015
Chennai
TAMIL NADU |
9677012723
Purushoth678@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: E106||Type 1 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Innovative Diabetic Foot Mat |
A portable, battery-operated diagnostic device designed to simultaneously detect plantar pressure hotspots and assess vibration perception threshold (VPT). 1)Pressure module: Identifies high-risk plantar pressure points (static/semi-dynamic assessment).
2)Vibration module: Quantifies vibration perception at standard foot sites (hallux, metatarsal heads, heel).
3)Purpose: Provides early diabetic foot ulcer risk stratification by combining biomechanical stress mapping and neuropathy assessment in a single session. Total duration of intervention -6months |
| Comparator Agent |
Tekscan F-Scan® in-shoe plantar pressure measurement system and Standard Biothesiometer |
1)Tekscan F-Scan®: A validated commercial device for dynamic plantar pressure mapping , providing peak plantar pressures, pressure–time curves, and center of force trajectories. Widely used in diabetic foot risk assessment and gait analysis.
2)Biothesiometer: A standard clinical device for quantitative vibration perception threshold measurement, considered the reference tool for detecting large-fiber neuropathy in diabetic patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
18 years or older.
Diagnosed with Type 1 or Type 2 diabetes mellitus.
Participants with or without peripheral neuropathy |
|
| ExclusionCriteria |
| Details |
History of foot or leg surgery within the last 6 months.
Presence of active infections or ulcers on feet.
Pregnant or planning to become pregnant during the study
period.
Any severe cardiovascular, neurological, or orthopedic
conditions that could affect the ability to participate. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to enhance diabetic foot
care by accurately identifying pressure points and
assessing vibration perception, leading to timely
interventions and improved patient outcomes. Additionally, it aims to empower patients and provide
valuable insights for healthcare providers in managing
diabetic complications. |
At baseline, at 4 weeks, and at 8 weeks after initial assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reliability of the innovative device |
Day 0 (15–30 min & within 2 h); Day 7 ±2 days. |
| Usability of the device |
Immediately after assessment on Day 0. |
| Patient comfort during device assessment |
Immediately after assessment on Day 0; optional safety/comfort check at 24 h ±6 h by phone. |
| Predictive ulcer risk |
Month 3 ±2 weeks; Month 6 ±3 weeks; Month 12 ±4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/10/2025 |
| 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
|
A novel device has been developed to improve care for diabetic patients by identifying pressure points and monitoring nerve function, aimed at preventing foot ulcers. The device uses a footscan pressure mat with multiple sensors and vibrators to assess plantar pressure and vibration perception threshold. The mat produces a color map and pressure curves for different foot regions, while the vibratory stimulus helps measure nerve function. This technology significantly reduces the risk of diabetic foot ulcers and neuropathy by addressing high-pressure areas and monitoring nerve health. Claims of the Invention • A PORTABLE PRESSURE SENSING AND VIBRATION PERCEPTION DEVICE FOR EARLY DETECTION OF PERIPHERAL NEUROPATHY IN DIABETES THROUGH WHICH WE CAN IMPLEMENT EFFECTIVE FOOTWEAR/OFFLOADING DEVICES. • EASY ACCESIBLE,COST EFFECIENT,TIME CONSUMING WITH ACCURATE READING S. |