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CTRI Number  CTRI/2024/11/077309 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The Antibiotic Resistance Patterns Among Diabetic Foot Infection Patients and Factors Associated in Causing the Infection 
Scientific Title of Study   Antibiotic Resistance Patterns and Predictors Associated with Limb Loss among Diabetic Foot Infection Patients : A Retrospective Cohort Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaniya Wilson 
Designation  PharmD Student 
Affiliation  PharmD  
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8792423718  
Fax    
Email  shaniyawilson2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Endocrinology and General Surgery, Justice K S Hegde Charitable Hospital, Deralakatte, Mangalore - 575018 
 
Primary Sponsor  
Name  Justice K S Hegde Charitable Hospital  
Address  Deralakatte, Mangalore-575018 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roopa Satyanarayan Basutkar  Justice K S Hegde Charitable Hospital  Inpatient Department of Endocrinology and General Surgery Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
9047155003

roopa.satyanarayan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with either Type 1 or Type 2 diabetes
2.Patients diagnosed with diabetic foot ulcer along with other comorbidities such as Hypertension, Stroke, CKD, PVD.
3.Patients who have undergone below-knee amputation as a result of DFI.
 
 
ExclusionCriteria 
Details  1.Patient’s medical records without culture and antibiotic susceptibility reports
2.Patients with other foot ulcers and foot infections not caused by diabetes
3.Outpatients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pattern of antibiotic resistance  At baseline visit 
 
Secondary Outcome  
Outcome  TimePoints 
Predictors for limb loss
Age
Complications
Retinopathy
Nephropathy
Neuropathy
Peripheral Vascular Disease
Gender
Type of DM
Type1 DM
Type 2 DM
Duration of diabetes
Type of Diabetic foot problems Gangrene
Cellulitis
Necrotizing fasciitis Charcot’s osteoarthropathy
Comorbidities
Hypertension
Ischaemic heart disease Chronic kidney disease
CAD
Pathogens
Risk factors
Alcoholism
Obesity
Smoking
Blood sugar levels
HbA1c greater than 6.5%
History of amputation History of debridement
 
At baseline visit 
 
Target Sample Size   Total Sample Size="514"
Sample Size from India="514" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 diabetic foot infection (DFI) is an infection of the bone or soft tissue that commonly affects  people with diabetes, especially those who also have peripheral vascular disease or neuropathy.   Diabetes duration and age both raise the risk of DFI. Patients who do not receive proper care for their diabetic foot ulcers (DFU) may experience diabetic foot osteomyelitis, which can lead  to gangrene and necessitate amputation. Most DFIs are polymicrobial, often multidrug- resistant (MDR), and capable of forming biofilms over time. Obtaining appropriate specimens for culture, correctly classifying lesions, making an accurate diagnosis, and carefully choosing empirical and definitive antimicrobial therapy are all necessary for effective infection management. This study aims to identify the factors that predict limb loss (below-knee  amputation) in individuals with DFI and to evaluate the culture results and antibiotic sensitivity.

 
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