| CTRI Number |
CTRI/2023/11/059965 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of a short educational program on the management of foot ulcers in diabetics |
|
Scientific Title of Study
|
Impact of a short educational program on the management of foot ulcers in diabetics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smruti Ratilal Ghetla |
| Designation |
Professor and Head of Department |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West.
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
|
| Fax |
|
| Email |
smruti.ghetla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West.
Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West.
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
7977023286 |
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aryan Tharewal |
| Designation |
Resident |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West.
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8975930301 |
| Fax |
|
| Email |
aryantharewal@gmail.com |
|
|
Source of Monetary or Material Support
|
| HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West. |
|
|
Primary Sponsor
|
| Name |
HBT Medical College andf Dr R N Cooper Municipal General Hospital |
| Address |
Juhu, Vile-Parle, Mumbai. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aryan Tharewal |
HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai. |
Department of General Surgery, HBTMC and RNCH, Juhu, Bhaktivedanta Marg, JVPD scheme, Vile-Parle West.ARLE WEST
Mumbai (Suburban)
MAHARASHTRA |
8975930301
aryantharewal@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: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. diabetic foot ulcer patients with ulceration of the dorsal and/or plantar aspect of the foot.
|
|
| ExclusionCriteria |
| Details |
1. patient undergoing inpatient treatment.
2. patients presenting with gangrene. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| how many patients benefitted from the knowledge imparted to them |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the impact of patient education on amputation rate in diabetic foot patients |
6 months |
| to find out the impact of patient education on adherence to treatment by glycaemic control in diabetic patients |
6 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
30/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Involving patients in their own treatment management protocol may improve their healing time of Diabetic Foot Ulcers and reduce their amputation rates. When patients are educated, and their caregiver is educated, patient adherence increases according to a study. This study intends to find a correlation between educational programs in Diabetic Foot Ulcer patients and bringing about improved healing/or recurrence rates. And whether amputation rates are decreased when patients are better educated. |