| CTRI Number |
CTRI/2026/01/100409 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of infection nerve and blood vessel status blood sugar control and wound severity in hospitalized patients with diabetic foot ulcers |
|
Scientific Title of Study
|
A clinical microbiological neurovascular and glycemic control study in diabetic foot ulcer and its correlation with severity of Wagner grading in hospitalized patients |
| 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 Mahalakshmi Subramani |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospitals salem |
| Address |
Department of general medicine Vinayaka missions kirupananda variar medical college and hospital salem
Salem
TAMIL NADU
636308
India |
| Phone |
9787730841 |
| Fax |
|
| Email |
mahasubramani9081@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirubhakaran |
| Designation |
Professor |
| Affiliation |
Vinayaka missions kirupananda variar medical college and hospital salem |
| Address |
Department of general medicine Vinayaka missions kirupananda variar medical college and hospital salem
Salem
TAMIL NADU
636308
India |
| Phone |
9786876687 |
| Fax |
|
| Email |
dr.kirubhakaranoffice@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahalakshmi Subramani |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospitals salem |
| Address |
Department of general medicine Vinayaka missions kirupananda variar medical college and hospital salem
Salem
TAMIL NADU
636308
India |
| Phone |
9787730841 |
| Fax |
|
| Email |
mahasubramani9081@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupananda variyar medical college and hospitals salem 636308 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Dr Mahalakshmi Subramani |
| Address |
Department of general medicine
Vinayaka missions kirupananda variyar medical college and hospitals salem 636308 Tamilnadu India |
| 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 Mahalakshmi Subramani |
Vinayaka missions kirupananda variyar medical college and hospitals salem |
Opd no 16 Department of general medicine Vinayaka missions kirupananda variyar medical college and hospitals salem
Salem
TAMIL NADU |
9787730841
mahasubramani9081@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka missions kirupananda variyar medical college and hospitals Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological 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 |
Patients diagnosed with Type 2 Diabetes Mellitus
Hospitalized patients with one or more clinically diagnosed diabetic foot ulcers
Age more than or equal to 30 years
Ulcers that can be graded using the Wagner classification system
Patients who give informed consent to participate in the study
Willingness to undergo clinical microbiological Retinal Renal and neurovascular assessment |
|
| ExclusionCriteria |
| Details |
Patients with non-diabetic foot ulcers example venous pressure or arterial ulcers unrelated to diabetes
Patients with malignant ulcers or ulcers secondary to autoimmune or vasculitic diseases
Individuals with severe comorbid conditions such as advanced malignancy end-stage renal disease on dialysis or terminal illness that could confound outcomes
Pregnant or lactating women
Patients who have received antibiotic treatment within the past 7 days before wound culture collection
Patients with incomplete clinical data or who are unable/unwilling to comply with study protocols
Patient with Type 1 Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is expected to demonstrate a strong correlation between Wagner grades and clinical microbiological neurovascular and metabolic findings in diabetic foot ulcers
Higher grades are anticipated to be associated with severe neuropathy poor vascular status and complex often resistant infections
Incorporating nephropathy retinopathy and glycemic control enhances prognostic accuracy
The findings aim to validate the Wagner system as a predictive tool for DFU severity support early identification of high risk patients and guide targeted treatment to reduce complications and hospital stays |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/01/2026 |
| 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="6"
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
|
Diabetic foot ulcer is a common and serious complication of diabetes mellitus often leading to infection prolonged hospitalization and risk of limb loss The severity of diabetic foot ulcers is commonly assessed using the Wagner grading system which helps guide management and prognosis This study aims to evaluate the clinical features microbiological profile neurovascular status and level of glycemic control in hospitalized patients with diabetic foot ulcers and to correlate these factors with the severity of ulcers based on Wagner grading Clinical assessment will include ulcer characteristics and associated comorbidities Microbiological evaluation will identify causative organisms and infection patterns Neurovascular assessment will focus on peripheral neuropathy and peripheral arterial disease Glycemic control will be assessed using blood glucose levels and HbA1c values By correlating these parameters with Wagner grades the study seeks to identify factors associated with more severe ulcers The findings may help in early risk stratification targeted treatment and improved prevention of complications such as infection and amputation in diabetic foot ulcer patients |