| CTRI Number |
CTRI/2025/09/095036 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Exploratory Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Creating a mobile application for patients suffering from foot problems due to diabetes. This application can be used by patients during recovery at home who have undergone an operation due to diabetes. |
|
Scientific Title of Study
|
Design and development of a self-management post-operative follow-up mobile application for patients with Diabetic foot. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MARIANNE SHRADDHA DSILVA |
| Designation |
PG STUDENT |
| Affiliation |
MGM School Of Biomedical Sciences, MGMIHS, NM |
| Address |
DEPARTMENT OF HEALTH INFORMATICS
CENTRAL RESEARCH LABORATORY(CRL)
ROOM NO. 2
MGM SCHOOL OF BIOMEDICAL SCIENCES
MGM INSTITUTE OF HEALTH SCIENCES (MGMIHS)
SECTOR 1
KAMOTHE
NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8291649562 |
| Fax |
|
| Email |
marianne.dsilva.3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARTHA PROTIM HAZARIKA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MGM School Of Biomedical Sciences, MGMIHS, NM |
| Address |
DEPARTMENT OF HEALTH INFORMATICS
CENTRAL RESEARCH LABORATORY(CRL)
ROOM NO. 2
MGM SCHOOL OF BIOMEDICAL SCIENCES
MGM INSTITUTE OF HEALTH SCIENCES (MGMIHS)
SECTOR 1
KAMOTHE
NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha01medinfo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PARTHA PROTIM HAZARIKA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MGM School Of Biomedical Sciences, MGMIHS, NM |
| Address |
DEPARTMENT OF HEALTH INFORMATICS
CENTRAL RESEARCH LABORATORY(CRL)
ROOM NO. 2
MGM SCHOOL OF BIOMEDICAL SCIENCES
MGM INSTITUTE OF HEALTH SCIENCES (MGMIHS)
SECTOR 1
KAMOTHE
NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha01medinfo@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM SCHOOL OF BIOMEDICAL SCIENCES, MGMIHS, NAVI MUMBAI |
|
|
Primary Sponsor
|
| Name |
MARIANNE SHRADDHA DSILVA |
| Address |
RSC 52
GORAI PRAGAT CHS
PLOT 60
ROOM 11
GORAI 2
BORIVALI WEST
MUMBAI 400092
MAHARASHTRA |
| 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 |
| DR PARTHA PROTIM HAZARIKA |
MGM HOSPITAL, KAMOTHE |
DEPARTMENT OF GENERAL SURGERY
SURGICAL DIVISION
GROUND FLOOR
ROOM NO. 13
SECTOR 1
KAMOTHE 410209
NAVI MUMBAI
Raigarh
MAHARASHTRA |
8451012070
partha01medinfo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAHATMA GANDHI MISSION DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for Information Gathering:
Specialisation: Medical Doctors specialising in diabetic foot care: podiatrists, endocrinologists and vascular surgeons.
Experience: At least 2 years of experience in treating diabetic foot patients.
Inclusion Criteria for Usability Testing:
1. Patients who have undergone surgery for diabetic foot.
2. Consenting patients.
3. Patients who can use a smartphone or have a caregiver to assist with using the application.
4. Patient or caregiver who can speak and understand the language in which the application is designed.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for Information Gathering:
Experience:
1. Doctors with less than 2 years of experience in diabetic foot care.
2. Specialists who are not willing to participate in the study.
Exclusion Criteria for Usability Testing:
1. Patients without access to a smartphone who are required to test the application.
2. Non-consenting patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Identify the user requirements for post-operative care of diabetic foot patients.
2. Design and develop a mobile application for post-operative care instructions of diabetic foot patients |
1) 3 months
2) 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/10/2025 |
| 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="1"
Months="0"
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
|
|