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CTRI Number  CTRI/2026/01/100164 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Epidemiology of lower limb amputations presenting to a tertiary care hospital 
Scientific Title of Study   Epidemiology of lower limb amputations presenting to a tertiary care centre  
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 Ankur garg 
Designation  post graduate junior resident orthopaedics 
Affiliation  PGIMS , Post graduate institute of medical sciences , rohtak  
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences, Rohtak PGIMS Pincode 124001 Rohtak HARYANA India

Rohtak
HARYANA
124001
India 
Phone  8570092630  
Fax    
Email  gargankur069@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohit khanna 
Designation  professor  
Affiliation  PGIMS , Post graduate institute of medical sciences , rohtak  
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences, Rohtak PGIMS Pincode 124001 Rohtak HARYANA India

Rohtak
HARYANA
124001
India 
Phone  9254340005  
Fax    
Email  drmohitkhanna0005@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohit khanna 
Designation  professor  
Affiliation  PGIMS , Post graduate institute of medical sciences , rohtak  
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences, Rohtak PGIMS Pincode 124001 Rohtak HARYANA India

Rohtak
HARYANA
124001
India 
Phone  9254340005  
Fax    
Email  drmohitkhanna0005@gmail.com  
 
Source of Monetary or Material Support  
department of orthopaedics ,Pgims rohtak 
 
Primary Sponsor  
Name  Dr Ankur garg 
Address  Department of Orthopaedics PGIMS Rohtak , pincode 124001, haryana  
Type of Sponsor  Other [(self)] 
 
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 Mohit khanna  Post graduate institute of medical sciences rohtak  Department of Orthopaedics Post Graduate Institute of Medical Sciences, Rohtak PGIMS Pincode 124001 Rohtak HARYANA India
Rohtak
HARYANA 
09254340005

drmohitkhanna0005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics comittee Pt .B.D. Sharma PGIMS/UHS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, (2) ICD-10 Condition: V899||Person injured in unspecified vehicle accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ALL patients who have undergone or will undergo lower limb amputations at department of orthopaedics PGIMS, Rohtak during the study period i.e.july 2024 to october 2025 
 
ExclusionCriteria 
Details  patients who declined consent or patients with incomplete medical records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
proportion and distribution of causes leading to lower limb amputations and complications post surgery  Immediate complications and
Within one week
 
 
Secondary Outcome  
Outcome  TimePoints 
association of comorbidities with lower limb amputation
demographic trends
post op short term outcomes 

Post op outcomes will be calculated at one week 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   15/01/2026 
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="3"
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  
Lower limb amputation is a major public health concern, often resulting in significant physical, psychological, social, and economic burden. The leading causes include trauma, diabetic complications, peripheral vascular disease, infections, and malignancies. The epidemiological profile of patients undergoing lower limb amputations varies across regions and healthcare setups, making it essential to generate local data for better planning of preventive and rehabilitative strategies.

This hospital-based cross-sectional observational study is being conducted at the Department of Orthopaedics,Pgims rohtak . The study aims to determine the epidemiology, demographic profile associated with lower limb amputations. All consecutive patients presenting to the hospital and undergoing amputation during the study period will be included after obtaining informed consent. Data will be collected on age, sex, occupation, socioeconomic status, comorbidities, indications, and levels of amputation.

The primary outcomes will include the proportion of different causes and levels of amputations. Secondary outcomes will include demographic trends, association of comorbidities, and short-term postoperative complications, if any. Data will be analyzed using descriptive and inferential statistics.

This study will provide valuable insights into the burden and patterns of lower limb amputations at a tertiary care hospital, which may help in planning preventive measures, patient counselling, and rehabilitation strategies.
 
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