| CTRI Number |
CTRI/2024/08/072345 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Novel light scattering based technique to identify microbes |
|
Scientific Title of Study
|
Detection of microbial pathogens associated with diabetic foot ulcer using Raman Spectroscopy and gold nano-particle based approaches |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TS Murali |
| Designation |
Professor & Head |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Department of Public Health Genomics, MSLS, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9741735278 |
| Fax |
|
| Email |
murali.ts@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Malatesh Devati |
| Designation |
Research Fellow |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Department of Public Health Genomics, MSLS, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9590406160 |
| Fax |
|
| Email |
malatesh.mslsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
TS Murali |
| Designation |
Professor & Head |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Department of Public Health Genomics, MSLS, MAHE
KARNATAKA
576104
India |
| Phone |
9741735278 |
| Fax |
|
| Email |
murali.ts@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 |
| Type of Sponsor |
Other [Private Deemed to be University] |
|
|
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 Rajgopal Shenoy |
Kasturba Hospital, Manipal |
Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9845243460
rajgopal.shenoy@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical COllege and Kasturba Hospital IEC |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known consenting Diabetes Mellitus patients aged between 18 and 60 years of age with ulcer/wound in the lower extremity of the body will be included in the study. |
|
| ExclusionCriteria |
| Details |
Non diabetic patients and patients whose etiology of wound is not related to diabetic state or its complications like varicose ulcers, vasculitis, specific infections (e.g. tuberculosis, actinomycosis etc.) and neoplastic will be excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome measures would be evaluation of diagnostic efficacy of SERS |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
26/08/2024 |
| 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="0"
Months="6"
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
|
In this study, we aim to address the urgent need for improved diagnostic tools for identifying microbial pathogens associated with Diabetic Foot Ulcers (DFUs) by evaluating the efficacy of Surface-Enhanced Raman Spectroscopy (SERS) in characterization of these pathogens. Chronic wounds in diabetic subjects can get infected by pathogenic microbes and if left untreated properly can even cause amputation of lower extremities. Hence, fast, reliable and sensitive diagnostic tools are the need of the hour. In this study, we aim to assess the accuracy and clinical applicability of SERS as well as use of gold-nanoparticles based diagnostic technique for rapid and accurate identification of microbial species associated with infected DFUs. The study explores the potential of these techniques to revolutionize point-of-care diagnostics in the context of DFUs, leading to improved patient outcomes and targeted therapeutic interventions. |