Peripheral Arterial Disease Clinical Trial
Official title:
Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
The circulation of blood around the body is dependent on effective pumping of the heart.
Patients with arterial insufficiency are known to have poor circulation in their lower legs
and feet leading to various complications such as swelling and painful legs and reduced
healing of injuries.
Peripheral arterial disease (PAD) can be defined as a narrowing of the arteries reducing
blood flow. It is most commonly due to atherosclerosis, and has associations with heart
disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population,
increasing with age to about 20% in the over-seventies. It is associated with effects on
mobility, skin condition and quality of life. Symptoms include pain in the legs on walking
(intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss.
Management of PAD is based on encouraging exercise, and modification of risk factors such as
smoking, high blood pressure, high cholesterol and diabetes.
In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be
treated via such as balloon angioplasty, stenting or surgical bypass, but these procedures
have risk. There also remains a percentage of patients who are not suitable for
revascularisation, and have only a few options such as amputation available to them.
Some trials have shown that increasing the blood flow in the legs over time using medical
devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal
medical and surgical therapy, can increase claudication distance, absolute walking distance,
decrease rest pain, and reduce amputation rates. In the investigators unit it has become
apparent that there are an increasing number of medical devices available for circulatory
support, either as an inpatient, out-patient, or a member of the general public. The
supporting evidence for these is variable in scientific and clinical content or relevance,
and requires clinical trials to evaluate further.
Revitive activates the pumping action of leg muscles by providing electrical muscle
stimulation to cause foot muscle contraction and relaxation which squeezes blood back towards
the heart, improving circulation.
The investigators wish to evaluate whether NMES using this device has the same beneficial
effects in patients with critical limb ischaemia.
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