| CTRI Number |
CTRI/2025/02/081022 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigation and Application of SINBAD Scoring System in Diabetic Foot Ulcer and Its Clinical Significance. |
|
Scientific Title of Study
|
Study Of Microbiological Spectra And Use Of SINBAD classification and scoring system in diabetic foot ulcer and its clinical relevance. |
| 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 Saurabh Gawand |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9359566339 |
| Fax |
|
| Email |
sgawand3355@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gattani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9359566339 |
| Fax |
|
| Email |
sakshigattani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh gattani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9359566339 |
| Fax |
|
| Email |
sakshigattani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College Sawangi Meghe wardha 442001 |
| Type of Sponsor |
Private 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 Saurabh Gawand |
Datta Meghe Institute of Higher Education and Research |
Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha Maharashtra 442001
Wardha
MAHARASHTRA |
9359566339
sgawand3355@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education And Research |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with diabetic foot ulcers
2. Patient age above 30 years |
|
| ExclusionCriteria |
| Details |
1. Patients with vascular disorders such as
vasculitis
2. Patients with leprosy
3. Patients with coexisting renal diseases
4. Those who do not wish to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use Of SINBAD classification and scoring system in diabetic foot ulcer. |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study Of Microbiological Spectra And Use Of S.I.N.B.A.D. classification & scoring system in diabetic foot ulcer & its clinical relevance. |
Two years |
|
|
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)
|
03/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A study of 50 patients diagnosed with diabetic foot ulcer via microbiological spectra with SINBAD grades to predict the outcomes in rural hospital in central india. Diabetes mellitus
affects all age groups and diabetic foot ulcer is more common in old age and is
associated with duration of diabetes mellitus. Male patients are more commonly
affected than female patients. Peripheral neuropathy, ischemia is vital predisposing
factor in pathophysiology of diabetic foot ulcer. However both aerobic &
anaerobic microorganisms involved in diabetic wound infection but among them
aerobic (mostly staphylococcus aureus) is more common. Commonest presenting
lesion in foot was mid/hind foot ulcer, developing spontaneously in the
background of neuropathy &vasculopathy. In the management of Diabetic foot
ulcers the very first prerequisite is strict blood sugar control, & early
identification and treatment of ulcers by detecting the organism & its
sensitive antibiotic and regular foot care is also important. The importance of
identifying the grade of ulcer & treating with appropriate antibiotics is
totally important for controlling infection and progression and thus preventing
limb amputation. In our set-up SINBAD grading is relevant and grade 4 being the
common one. The empirical antibiotic that can be started for infected diabetic
foot ulcer in our set up is piperacillin tazobactem followed by imipenam &
Amikacin.
|