Status:
COMPLETED
Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?
Lead Sponsor:
Imperial College London
Conditions:
Intermittent Claudication
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the manag...
Eligibility Criteria
Inclusion
- Capacity to provide informed consent
- Aged 18 or above
- Positive Edinburgh Claudication Questionnaire
- ABPI \<0.9 OR positive stress test (fall in ankle pressure \>30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)
Exclusion
- Severe IC requiring invasive intervention as determined by the treating clinician
- Critical limb Ischaemia as defined by the European Consensus Document
- Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
- Popliteal entrapment syndrome
- Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
- Pregnancy
- Any implanted electronic, cardiac or defibrillator device
- Acute deep vein thrombosis
- Broken or bleeding skin including leg ulceration
- Peripheral neuropathy
- Recent lower limb injury or lower back pain
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03446027
Start Date
February 16 2018
End Date
September 30 2021
Last Update
April 11 2024
Active Locations (11)
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1
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Bournemouth, United Kingdom
2
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
4
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom