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A Randomised Study on Enhanced Recovery Protocol for Early Ambulation After Lower Limb Amputation in Patients with Peripheral Arterial Disease

Enhanced recovery pathway for lower limb amputations in peripheral arterial disease: randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090850
Enrollment
50
Registered
2025-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities

Interventions

Intervention1: 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.

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Trauma and burn patients Non-ambulatory patients H/O contralateral amputation

Design outcomes

Primary

MeasureTime frame
Postoperative length of stay (PO-LOS) Timepoint: 3 DAYS

Secondary

MeasureTime frame
Time to receipt of prosthesisTimepoint: Measured from date of surgery to prosthesis application ( week 8);Time to independent ambulationTimepoint: Measured from date of surgery to first documented independent ambulation (month 3)

Countries

India

Contacts

Public ContactAKANKSHA KUMARI

PGIMER,Chandigarh

drajaysavlania@gmail.com9988130747

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026