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Electrical Stimulation in Peripheral Arterial Disease

Not Applicable
Terminated
Conditions
Peripheral Arterial Disease
Interventions
Device: Bilateral NMES legs
Other: Best medical therapy
Registration Number
NCT02136537
Lead Sponsor
Imperial College London
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging
  • ABPI<0.9
  • Absolute walking distance <500m
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Exclusion Criteria
  • Pregnancy
  • Cardiac pacemaker
  • Previous lower limb major amputation
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Best medical therapy plus NMESBilateral NMES legsIn addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
Best medical therapy plus NMESBest medical therapyIn addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
Best medical therapyBest medical therapyClaudicants treated according to local protocol - no added treatment
Primary Outcome Measures
NameTimeMethod
Absolute walking distance6 weeks

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

Secondary Outcome Measures
NameTimeMethod
Claudication distance6 weeks

Treadmill test (as per absolute walking distance)

Trial Locations

Locations (1)

Charing Cross Hospital

🇬🇧

London, United Kingdom

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