| CTRI Number |
CTRI/2025/07/090850 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Study on Enhanced Recovery Protocol for Early Ambulation After Lower Limb Amputation in Patients with Peripheral Arterial Disease |
|
Scientific Title of Study
|
Enhanced recovery pathway for lower limb amputations in peripheral arterial disease: randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKANKSHA KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER, Chandigarh |
| Address |
DEPARTMENT OF GENERAL SURGERY, 5TH LEVEL, B - BLOCK,
NEHRU HOSPITAL, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6392727549 |
| Fax |
|
| Email |
akankshafzd2508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AJAY SAVLANIA |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
PGIMER,Chandigarh |
| Address |
DEPARTMENT OF GENERAL SURGERY, 5TH LEVEL, B - BLOCK,
NEHRU HOSPITAL, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988130747 |
| Fax |
|
| Email |
drajaysavlania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKANKSHA KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER,Chandigarh |
| Address |
DEPARTMENT OF GENERAL SURGERY, 5TH LEVEL, B - BLOCK,
NEHRU HOSPITAL, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6392727549 |
| Fax |
|
| Email |
akankshafzd2508@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POST GRADUATE INSTITUTE OF MEDICAL COLLEGE AND HOSPITAL |
| Address |
PGIMER CHANDIGARH INDIA PIN-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akanksha Kumari |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF
GENERAL SURGERY,
5TH LEVEL, B
BLOCK, NEHRU
HOSPITAL, POST
GRADUATE
INSTITUTE OF
MEDICAL EDUCATION
AND RESEARCH
CHANDIGARH-12
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
6392727549
akankshafzd2508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LEAP protocol |
Day 1: Foley catheter removal, physiotherapy begins, occupational therapy assessment.
• Day 2–3: Pain and wound evaluated; discharge planned if stable.
• Upon Discharge: Follow-up coordinated via designated amputation coordinator.
Follow-up Phase:
• Week 3: Staple removal and prescription for stump shrinker/prosthesis.
• Week 5: Limb moulding for prosthesis.
• Week 8: Prosthesis application and outpatient physiotherapy begins.
• Month 3: Ambulation assessment and final surgical review. |
| Comparator Agent |
Traditional postoperative care |
Routine perioperative care without enhanced recovery strategies or standardised rehabilitation pathways. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age above 40 years
Diagnosed peripheral arterial disease
Clinical WiFi stage 5 with unsalvageable limb
Ankle Brachial Index less than 0.9 or more than 1.2 (non-compressible arteries)
Provided informed consent |
|
| ExclusionCriteria |
| Details |
Trauma and burn patients
Non-ambulatory patients
H/O contralateral amputation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative length of stay (PO-LOS)
|
3 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to receipt of prosthesis |
Measured from date of surgery to prosthesis application ( week 8) |
| Time to independent ambulation |
Measured from date of surgery to first documented independent ambulation (month 3) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2025 |
| 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="0"
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
|
This randomized control trial aims to evaluate the effect of an enhanced recovery pathway on patients undergoing major lower limb amputation due to peripheral arterial disease (PAD). The intervention group will receive a multidisciplinary LEAP protocol-based care that includes prehabilitation, perioperative physiotherapy, multimodal analgesia, early mobilisation, and prosthetic counselling. The control group will receive traditional postoperative care. The primary outcome is postoperative length of stay. Secondary outcomes include time to prosthesis application and time to independent ambulation. A total of 50 patients will be enrolled (25 in each group). The study will be conducted in the Department of General Surgery, PGIMER, Chandigarh from January 2025 to January 2026 |