| CTRI Number |
CTRI/2024/07/070572 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study Conducted To Assist the Factors Associated With Amputation Among Diabetic Foot Ulcer Patients |
|
Scientific Title of Study
|
Factors Associated With Amputation Among Diabetic Foot Ulcer Patients - A Retrospective 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 |
M Adhithya |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte,
Mangaluru Dakshina Kannada KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7306328009 |
| Fax |
|
| Email |
adhithyamelath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Barma Nagu Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of pharmaceutical sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte,
Mangaluru Dakshina Kannada KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Caren D Souza |
| Designation |
Professor and unit head |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of General Surgery
Justice KS Hegde Charitable Hospital
Deralakatte Mangaluru 575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
81470013238 |
| Fax |
|
| Email |
drcaren@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Deralakatte Mangaluru |
| Justice KS Hegde Charitable Hospital Deralakatte Mangalore 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Caren D Souza |
Justice K S Hegde Charitable Hospital |
Department of General Surgery
Justice K S Hegde Charitable Hospital Deralakatte Mangaluru
Deralakatte
Mangaluru
Dakshina Kannada
Karnataka
575018
Dakshina Kannada
KARNATAKA |
8147003238
drcaren@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences - Institutional Ethics Committee |
Approved |
| NGSM Institute of Pharmaceutical Sciences - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years
Both gender patients
Diagnosed with either Type 1 or Type 2 DM
Diagnosed with DFU |
|
| ExclusionCriteria |
| Details |
Traumatic any ulcers other than DFU
Other foot infections/ abscess
Pregnancy and lactation women
Cognitive, psychiatry and terminal illness patients
Patient data with incomplete records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of amputations among the diabetic foot ulcer patients. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the factors associated with amputations among the diabetic foot ulcer patients. |
July 2024 to February 2025 |
|
|
Target Sample Size
|
Total Sample Size="640"
Sample Size from India="640"
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)
|
27/07/2024 |
| 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="8"
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
|
The study will be conducted to determine the proportion of amputations among the diabetic foot ulcer patients and to identify the factors associated with amputations among the diabetic foot ulcer patients. It will be a Retrospective observational study of 8 months duration and will be conducted in the Medical records department, Justice K.S. Hegde Charitable Hospital, Deralakatte,Mangaluru . Retrospective data (of both gender patients above 18 years old diagnosed with Type 1 or Type 2 Diabetes Mellitus, Diabetic Foot Ulcer) from 1st January 2021 to 31st December 2023 (approximately 640) will be included in the study.The patient demographic details such as age, gender, place of residence, type of diabetes, duration of diabetes and DFU, BMI, comorbidities, osteomyelitis, smoking, serum protein level, Hb1Ac, amputation related information etc. will be collected. |