| CTRI Number |
CTRI/2025/03/082103 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Benefits of topical application of insulin in Diabetic foot ulcer. |
|
Scientific Title of Study
|
Benefits of Topical insulin in diabetic foot ulcer: Study in Tertiary Care centre of Southern Odisha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Biswajita Rautaray |
| Designation |
Post graduate Resident |
| Affiliation |
MKCG Medical college and Hospital |
| Address |
Department of General Surgery
Mkcg medical college and hospital.
Berhampur. Ganjam.
Odisha.
Ganjam
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
rautaraybiswajita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswajita Rautaray |
| Designation |
Post graduate Resident |
| Affiliation |
Department of General Surgery.MKCG Medical college and Hospital |
| Address |
Mkcg medical colleg and hospital.
Department of General Surgery Berhampur . Ganjam. Odisha.
Berhampur Ganjam
Ganjam
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
rautaraybiswajita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswajita Rautaray |
| Designation |
Post graduate Resident |
| Affiliation |
MKCG Medical college and Hospital |
| Address |
Mkcg medical college.
Department of General Surgery Berhampur . Ganjam.
760004
Berhampur Ganjam
Ganjam
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
rautaraybiswajita@gmail.com |
|
|
Source of Monetary or Material Support
|
| MKCG MEDICAL COLLEGE AND HOSPITAL
Berhampur, Ganjam.
Odisha. 760004 |
|
|
Primary Sponsor
|
| Name |
Mkcg medical college and hospital |
| Address |
Berhampur. Ganjam. Odisha.
India. 760004 |
| 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 |
| Dr Biswajita Rautaray |
MKCG MEDICAL COLLEGE AND HOSPITAL |
Department of General Surgery
Surgery Block. 3rd floor.
Ganjam
ORISSA |
7978183406
rautaraybiswajita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICS COMMITTEE , MKCG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mixtrad insulin |
Topical application in dressing of diabetic foot ulcer.
Alternate day dressing for 14 days. 4 unit mixtrad insulin in 1ml NS. Sterile gauze 10ml per 10cm2 of ulcer to be given as dressing . |
| Comparator Agent |
Normal saline |
Topical application for dressing of diabetic foot ulcer.
Alternative day dressing for 14 days.
NS soaked gauze will be applied for dressing. 10ml for 10cm2 of wound |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic foot ulcer |
|
| ExclusionCriteria |
| Details |
Active Osteomyelitis
HIV/ HBsAg positive
Denied consent
Severe anemia
Occlusion of major vessel of leg |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early granulation
Complete primary healing |
0 7, 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Better graft uptake
Low infection rate
Decreased hospital stay |
0, 7 15 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/04/2025 |
| 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
|
Diabetes and its complications have been in increasing trend owing to the lifestyle changes and awareness. The cases of Diabetic foot disease are equally increasing. Diabetic foot is a debilitating condition affecting the quality of life of an individual. Thus novel clinical interventions in aiding to the early recovery of this debilitating condition is the need of hour.The complications of diabetics have been attributed to the local tissue hyperglycemia leading to micro and macrovascular changes.This trial aims to determine the benefits of topical application of insulin in dressing of diabetic foot ulcer as compared to traditional normal saline dressingin terms of speed of recovery, early granulation, graft uptake and hospital stay. |