FAQs

A combination of smoking, diabetes, high blood pressure, high cholesterol levels, chronic kidney disease and the ageing process, results in some people developing ‘hardening’ of the arteries (atherosclerosis) in their legs. Atherosclerosis can narrow or block lower limb arteries so reducing the blood supply to the legs and feet. If the disease progresses, poor blood supply to the leg can lead to severe pain all the time (ischaemic rest pain), especially at night (ischaemic night pain). At this stage, even minor foot injuries can fail to heal, resulting in the development of tissue loss by ulceration, even gangrene, following infection.

The presence of ischaemic rest / night pain, with or without tissue loss, is termed critical or severe limb ischaemia (SLI).

One in every 1000-2000 people in the UK will be diagnosed with SLI each year and the incidence of SLI is rising principally as a result of our ageing population, the increasing numbers of people with diabetes, and high rates of smoking.

Without improvement of the blood supply to the leg and foot, many people affected by SLI will lose their limb and/or die within 12 months.  As well as causing great suffering, SLI places a large economic burden upon health (NHS) and social care services. SLI is a growing global healthcare problem affecting every country in the world.

BASIL-2 will recruit potential patients via a number of regional co-ordinating recruitment centres throughout England & Scotland. Each regional centre will be sub-contracted by the University of Birmingham to achieve an agreed level of recruitment from their region.

All patients with SLI presenting at a participating centre will be "screened". Screening consists of asking for the patients permission for members of the research team to look at their medical records now and in the future to see which patients enter the trial, which don't, and the outcomes for each group. These patients will continue to diagnosis using the same methods and tests that are always used for this patient group. At the conclusion of any "diagnostic work-up", a group of specialists will decide at a multi-disciplinary team (MDT) meeting if the patient is suitable to enter the trial. If the MDT decides they are suitable, the patient will offered the opportunity to provide consent and participate. Patients may be presented with trial information at any suitable stage in this pathway provided they are made aware that their suitability for the trial is merely a possibility and that the MDT may decide that the trial, for them, may not be the best treatment option.

If a patient is suitable for the trial and does want to participate, then after providing written informed consent they will be randomised to receive either vein bypass surgery or the best endovascular treatment. The chance of receiving one of the treatments will be 50%. Half of all patients entering the trial will be randomised to receive a vein bypass and the other half will receive best endovascular treatment. Randomisation will be done via a computer and neither the patient or the doctor can choose which treatment a trial patient will receive.

Information will be collected for all patients for a minimum of two years and a maximum of eight years after entering the study. At the end of this time the information will be analysed to see if one of the treatments is better than the other.

The BASIL-2 trial is funded by a NIHR Health Technology Assessment grant (reference 12/35/45).

The results of the BASIL-2 trial were published in The Lancet on 25 April 2023, and simulataneously presented at The Charing Cross International Symposium in London.

In summary, 108 out of 172 people (63%) people in VB group had a major amputation or died, compared to 92 out of 173 people (53%) people in BET group.  This means that a VB first strategy was associated with an increased risk of major amputation or death compared with a BET first strategy.  

 Our findings suggest a greater role for best endovascular treatment first strategy in the management of patients with CLTI who require an infra-popliteal revascularisation to restore limb perfusion.