Electrical Stimulation in Peripheral Arterial Disease

NCT ID: NCT02136537

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Best medical therapy

Claudicants treated according to local protocol - no added treatment

Group Type ACTIVE_COMPARATOR

Best medical therapy

Intervention Type OTHER

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.

Best medical therapy plus NMES

In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.

Group Type EXPERIMENTAL

Bilateral NMES legs

Intervention Type DEVICE

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 therapy

Intervention Type OTHER

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.

Interventions

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Bilateral NMES legs

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

Intervention Type DEVICE

Best medical therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AH Davies

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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14HH2054

Identifier Type: OTHER

Identifier Source: secondary_id

14/LO/0854

Identifier Type: -

Identifier Source: org_study_id

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