Does neuromuscular electrical stimulation improve the absolute walking distance in patients with intermittent claudication (nesic) compared to best available treatment? A multicentre randomised controlled study

Overview

2019 Protocol article in https://doi.org/10.1016/j.jvs.2018.10.046 protocol (added 08/03/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37748866/ (added 26/09/2023)

Registry

who.int

Start Date

November 28, 2017

End Date

March 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Capacity to provide informed consent
•2\. Aged 18 years or above
•3\. Positive Edinburgh Claudication Questionnaire
•4\. ABPI \<0\.9 OR positive stress test (fall in ankle pressure \>30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)

•1\. Severe IC requiring invasive intervention as determined by the treating clinician
•2\. Critical limb ischaemia as defined by the European Consensus Document
•3\. Co\-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
•4\. Popliteal Entrapment Syndrome
•5\. Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
•6\. Pregnancy. Participants must be of non\-childbearing potential\* OR using adequate contraception for the duration of the study period and have a negative urine pregnancy test result
•7\. Any implanted electronic, cardiac or defibrillator device
•8\. Acute Deep Vein Thrombosis
•9\. Broken or bleeding skin including leg ulceration
•10\. Peripheral neuropathy