Leg Ischaemia Management Collaboration (LiMb) version 1.0
Research type
Research Study
Full title
Leg Ischaemia Management Collaboration (LiMb)
IRAS ID
243053
Contact name
RD Sayers
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
11 years, 11 months, 31 days
Research summary
Peripheral arterial disease is a common cardiovascular disease that can cause blocked blood vessels in the leg. Patients develop pain caused by lack of blood flow and often gangrene and ulceration. Many patients are diabetic or have been heavy smokers. They are usually admitted to hospital for investigations and management. Current treatment options include drainage of infections and amputation of toes, balloon treatment to expand blocked arteries and surgical bypass operations. Unfortunately despite attempts to save the leg, a major amputation around the knee area is often required. In some patients with severe disease this may be the only option from the start.
Our approach to manage these patients has recently changed to coincide with the relocation of the Leicester Vascular Institute to Glenfield Hospital. We have introduced a daily rapid access clinic to see urgent referrals and updated some of our protocols to make them more patient focussed, resulting in a new comprehensive enhanced care pathway for these patients.
We plan to investigate the short and long term outcomes of these patients to improve the way we treat them. We propose to recruit and study a group of patients with very poor leg circulation who attend the Leicester Vascular Institute at Glenfield hospital. We plan to assess their frailty, memory and heart function to see if they get worse in hospital, assess their quality of life over the 24 months following their attendance, and determine whether the patient dies or loses their leg over the 10 years (long-term outcomes) following their attendance.
This study may allow us to decide in the future what is the best treatment for these patients' and ensure that we don’t offer the highest risk treatment to patients who are too frail or ill to withstand it, or for whom alternative interventions might in fact offer better outcomes.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0132
Date of REC Opinion
11 Feb 2019
REC opinion
Favourable Opinion