Electrical Stimulation in Peripheral Arterial Disease

N/ATerminatedNCT02136537

Imperial College London40 enrolled

Overview

The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Bilateral NMES legsDEVICE

Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve

Best medical therapyOTHER

Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of stable intermittent claudication (\>6 months) with confirmation by medical imaging * ABPI\<0.9 * Absolute walking distance \<500m Exclusion Criteria: * Pregnancy * Cardiac pacemaker * Previous lower limb major amputation

Locations (1)

Charing Cross Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Absolute walking distance

Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%

Time frame: 6 weeks

Secondary Outcomes

Claudication distance

Treadmill test (as per absolute walking distance)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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