| CTRI Number |
CTRI/2024/10/075732 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Autologous Fat Grafting for Diabetic for ulcers |
|
Scientific Title of Study
|
Prospective randomised study to compare autologous fat graft with standard of care versus standard of care alone in healing of diabetic foot ulcer at a tertiary care centre in central India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDaniel Raj |
| Designation |
M.S. General Surgery |
| Affiliation |
M.G.M Medical College and M.Y. Hospitals, Indore |
| Address |
DEPARTMENT OF SURGERY, MGMMC & MYH, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9884238791 |
| Fax |
|
| Email |
darwin.d.raj18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonia Moses |
| Designation |
M.S. General Surgery |
| Affiliation |
M.G.M Medical College and M.Y. Hospitals, Indore |
| Address |
DEPARTMENT OF SURGERY, MGMMC & MYH, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9827324829 |
| Fax |
|
| Email |
drsoniamoses@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDaniel Raj |
| Designation |
M.S. General Surgery |
| Affiliation |
M.G.M Medical College and M.Y. Hospitals, Indore |
| Address |
DEPARTMENT OF SURGERY, MGMMC & MYH, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9884238791 |
| Fax |
|
| Email |
darwin.d.raj18@gmail.com |
|
|
Source of Monetary or Material Support
|
| MY hospital, Indore, MP (PIN - 452001) |
| N/A |
|
|
Primary Sponsor
|
| Name |
Department of Surgery MGM Medical College Indore |
| Address |
Indore, MP (PIN - 452001) |
| 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 Daniel Raj |
MY hospital |
Department of Surgery
Indore
MADHYA PRADESH |
9884238791
darwin.d.raj18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS AND SCIENTIFIC REVIEW COMMITTEE M.G.M.MEDICAL COLLEGE &M.Y.HOSPITAL, INDORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L974||Non-pressure chronic ulcer of heeland midfoot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Fat Grafting with standard of care for Diabetic foot ulcer |
Using fat harvested from patient to apply/ infiltrate in Diabetics Foot ulcer of that same patient for wound healing.
Amount - 3-5 ml depending on wound size once and then follow up with examining and dressing of wounds at regular intervals
Duration - 8-10 weeks |
| Comparator Agent |
Standard of care alone for management of Diabetic foot Ulcer |
Using standard proven methods to manage diabetic foot ulcer such as Debridement and dressing
For 8 - 10 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients with diabetic foot ulcers between ages 30 to 80 |
|
| ExclusionCriteria |
| Details |
Wound with active infection .
Patients with uncontrolled blood sugar levels.
Patients with coagulating defects.
Immunocompromised patients.
Patients with severe vascular insufficiency.
Patients of diabetic foot ulcer with deranged renal function
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the change in area of wound size of diabetic foot ulcer after autologous fat graft and standard care versus standard care only
Measurement shall be done using a ruler |
Wound measurement at 2,4,6,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the continuous and category variables of diabetic foot ulcer patients.
To determine the effect of risk factors on occurrence of diabetic foot ulcer |
During the duration of study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/11/2024 |
| 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="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
|
To measure the change in area of wound size of diabetic foot ulcer after autologous fat graft and standard care vs. standard care only. Measurement shall be done using a ruler. |