Intermittent claudication Circulatory System Diseases of arteries, arterioles and capillaries
Conditions
Interventions
Participants meeting the eligibility criteria are randomised into two arms using a computer:
Arm 1 (Control): locally available therapy.
Arm 2 (Intervention): locally available therapy + NMES device
Sponsors
Imperial College of Science, Technology and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capacity to provide informed consent 2. Aged 18 years or above 3. Positive Edinburgh Claudication Questionnaire 4. ABPI 30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute walking distance (AWD) is measured using treadmill testing at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial claudication distance (ICD) is measured using treadmill testing at baseline, 3 month, 6 month and 12 months 2. Quality of Life (QoL) is measured using validated questionnaires (Intermittent Claudication Questionnaire (ICQ), EuroQoL 5D (EQ5D-5L), Short Form 36 (SF-36)) at baseline, 3 month, 6 month and 12 months 3. Haemodynamics are measured using Duplex ultrasonography*, Laser Doppler Flowmetery (LDF) and Ankle Brachial Pressure Index (ABPI) at baseline, 3 month, 6 month and 12 months *performed at baseline and 3 months only. 4. Health economic assessment is measured using validated QoL questionnaires and compliance data at baseline, 3 month, 6 month and 12 months 5. Compliance with interventions is measured using patient compliance diaries and data loggers at 3 months 6. Device experience questionnaire is measured using patient device experience questionnaire at 3 months | — |
Countries
England, United Kingdom
Outcome results
None listed