Evaluating the benefits of a neuromuscular electrical stimulation (NMES) device in patients with intermittent claudicatio

Not Applicable

Completed

• Conditions: Intermittent claudication; Circulatory System; Diseases of arteries, arterioles and capillaries

• Registration Number: ISRCTN18242823
• Lead Sponsor: Imperial College of Science, Technology and Medicine

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study Completion: 2021-03-31
• Last Update Posted: 2023-10-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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)

Exclusion Criteria

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
11. Recent lower limb injury or lower back pain

* defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for greater than 12 months and has an FSH greater than 40 IU/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified