| CTRI Number |
CTRI/2024/05/067026 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of local Insulin Injection for wound healing in cases of Diabetic Foot ulcers |
|
Scientific Title of Study
|
Effect of local insulin injection for wound healing in cases of Diabetic foot ulcers - A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarushi Srivastava |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College, Pondicherry Cuddalore Road, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7398688410 |
| Fax |
|
| Email |
94.raashi.as@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarushi Srivastava |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College, Pondicherry Cuddalore Road, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7398688410 |
| Fax |
|
| Email |
94.raashi.as@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarushi Srivastava |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College, Pondicherry Cuddalore Road, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7398688410 |
| Fax |
|
| Email |
94.raashi.as@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College, Pondicherry Cuddalore Road, Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Aarushi Srivastava |
| Address |
Aarupadai Veedu Medical College, Pondicherry Cuddalore Road, Pondicherry 607402 |
| 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 Aarushi Srivastava |
Aarupadai Veedu Medical College |
Department of General Surgery OPD no. 10
Aarupadai Veedu Medical College, Pondicherry
607402
Pondicherry
PONDICHERRY |
7398688410
94.raashi.as@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aarupadai Veedu Medical College institutional human ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local insulin injection |
Local insulin injection in diabetic foot ulcer
According to sliding scale dose of insulin will be decided after checking blood glucose level
The decided dose will be divided into half
1st half will be mixed with normal saline to make a total of 1ml and injected into the ulcer.
2nd half will be given as usual subcutaneously at the site of daily insulin
This injection of local insulin in the ulcer will be done once a day at the time of daily dressing |
| Comparator Agent |
Normal saline |
Normal saline dressing in diabetic foot ulcer
Daily wound cleaning followed by dressing done with normal saline soaked gauze piece |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary Participants
Ulcer duration more than 3 weeks |
|
| ExclusionCriteria |
| Details |
Patients with extensive necrosis which require immediate amputation
Patients on immunosuppressives, radiotherapy, corticosteroids, anticoagulants
Patients who discontinue therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Size of Ulcer
Granulation
Pus culture / Sensitivity |
Day O, 1,3,7,14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Possible side effects of local Insulin |
Day 0-14 |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [94.raashi.as@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Diabetic foot is a common complication of diabetes which is associated with various factors for wound healing. Aim of the present study is to investigate the effect of Local insulin injection on wound healing in a diabetic foot ulcer as compared to conventional Normal saline dressing |