| 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
|
|
|
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
|
|
|
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.
|