NCT02634138

Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.

Detailed description

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.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischaemia

Interventions

Type	Name	Description
DEVICE	Revitive IX	A foot plate Neuromuscular Electrical Stimulation Device

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-12-17
• Last updated: 2019-06-06

Locations

1 site across 1 country: United Kingdom