| CTRI Number |
CTRI/2024/06/069160 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of AI for early detection of diabetic foot complications. |
|
Scientific Title of Study
|
Design and Development of AI-based solution to predict the early stage of diabetic foot complications empowering diabetic foot care |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariya Jiandani |
| Designation |
Associate Professor |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Cardio thoracis vascular center Building, Room No 16, Ground Floor, Seth G S Medical College and KEM Hospital,
Parel East, Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820191106 |
| Fax |
|
| Email |
mpjiandani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariya Jiandani |
| Designation |
Associate Professor |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Cardio thoracis vascular center Building, Room No 16, Ground Floor, Seth G S Medical College and KEM Hospital,
Parel East, Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820191106 |
| Fax |
|
| Email |
mpjiandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Taranga Joshi |
| Designation |
PG Student |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Cardio thoracis vascular center Building, Room No 16, Ground Floor, Seth G S Medical College and KEM Hospital,
Parel East, Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9987104222 |
| Fax |
|
| Email |
tarangajoshi106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School & Centre Seth G S Medical College & KEMH |
|
|
Primary Sponsor
|
| Name |
Physiotherapy School & Centre Seth G S Medical College & KEMH |
| Address |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School
and Centre, Seth G S Medical College and KEM Hospital, Parel
East, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mariya Jiandani |
Physiotherapy School and Centre, Seth GS Medical College and KEM Hospital |
Room No 16, Ground
Floor, CVTC Building,
Physiotherapy School
and Centre, Seth G S
Medical College and
KEM Hospital, Parel
East, Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
09820101196
mpjiandani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth GS Medical Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers from age 30 to 70 without type 2 diabetes |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
People with type 2 diabetes mellitus
People with type 2 diabetes mellitus and diagnosed with diabetic foot complications
Normal Healthy individuals
Both gender (Male/Female)
30-70 years
|
|
| ExclusionCriteria |
| Details |
People with venous foot ulcerations
People with bilateral Syme’s Amputation and above
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of machine learning algorithm for early detection of diabetic foot complication. |
Baseline one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| App Usability questionnaire |
Post 3 weeks of application delivery to the user |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/06/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes mellitus (DM) is a
chronic, continually growing metabolic disease that can be brought on by an
inability to produce insulin or by an intolerance to the hormone. The number of
estimated sufferers in India is 77 million.
Diabetic foot complications (DFC) include neuropathies, calluses, poor
circulation, and foot ulcers caused by ischemia, neuropathy, and microvascular
and macrovascular damage. DFC is a common but serious complication of diabetes
mellitus (DM). These issues contribute to morbidity and mortality by
facilitating the development of infections, ulcers, and gangrene. Diabetic foot lesions not only result in pain
and morbidity but also have major financial consequences. Early detection of DFC and foot
care practices as a preventive measure have shown promising results in
prevention of DFC. Hence the aim of the study is to develop and design AI based solution for early diagnosis of diabetic foot complications and to empower foot care practices. |