| CTRI Number |
CTRI/2024/05/067388 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of foot care education module on practices of foot care in patients with diabetic foot complications and factors affecting foot care practices. |
|
Scientific Title of Study
|
Evaluation of digital education Module in patients with diabetic foot complications and factors affecting foot care practices: A mixed method Study |
| 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 |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and
KEM Hospital, Parel East, Mumbai
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 |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and
KEM Hospital, Parel East, Mumbai
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 |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and
KEM Hospital, Parel East, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9987104222 |
| Fax |
|
| Email |
tarangajoshi106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and
KEM Hospital, Parel East, Mumbai-400012, Maharashtra, India |
|
|
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 |
9820191196
mpjiandani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Project Stride- An educational tool |
An educational tool regarding the foot care practices. It contains 5 modules which give information on 1. Diabetes and its complications 2. Foot care 3. Skin Care 4. Footwear Care 5. General Instructions.
At baseline the pre Knowledge and practice questionnaires will be filled by the participants. The educational booklet will be provided to them and for 6 weeks, weekly zoom calls or whats up calls will be held.
Post 6 weeks post questionnaires will be filled by the participants. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
People diagnosed with diabetic foot complications and Unilateral Foot amputations |
|
| 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 |
Knowledge Questionnaire by Hasan et al
Nottingham Assessment of Functional Foot Care for practice |
2
Baseline
6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Interviews will be conducted of those whose practices did not improve post 6 weeks after filling the post questionnaires. (Practice scores
above 70% are considered as good practices.)
Interview Questions:
1. What were the things that motivated you to keep practicing good foot cares?
2. How did you feel after following the foot care practices?
3. What were the difficulties faced by you? How did you overcome them?
4. What were the things that stopped you from practicing foot care ?
5. Was this module helpful to you ?If yes how? If no why?
6. Were you satisfied with this module? |
At the end of 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
26/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Diabetes mellitus (DM) is a long-term, progressive metabolic condition that can be caused by either a lack of insulin or by a resistance to the hormone. It has an impact on public health worldwide, With an estimated 451 million sufferers globally. A common but serious complication of diabetes mellitus (DM) is diabetic foot complications (DFC). The best method for treating DFCs is preventive medicine. According to the literature there is poor knowledge and practice of foot care. The main reason for the same is lack of educational tool. Hence the study aims to deliver foot care educational module in patients with diabetic foot complications and evaluate the change in foot care practices post delivery, also the study aims to identify the factors influencing practice of foot care if any.
|