| 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
|
|
|
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
|
|
|
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. |