Electrical Stimulation in Peripheral Arterial Disease (PAD)

May 8, 2019 updated by: Imperial College London
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Best medical therapy
Claudicants treated according to local protocol - no added treatment
Other: 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.
Experimental: Best medical therapy plus NMES
In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
Other: 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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute walking distance
Time Frame: 6 weeks
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Claudication distance
Time Frame: 6 weeks
Treadmill test (as per absolute walking distance)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: AH Davies, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/LO/0854
  • 14HH2054 (Other Identifier: Imperial College JRCO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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