BACKGROUND: Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. METHODS: In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. RESULTS: Study 1 (20 patients) showed a significant improvement in MCD (46%; p < 0.001) and ICD (71%; p < 0.001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46%; p = 0.014). Improvements were seen in the ICQ (9 points; p = 0.009) and EQ-5D-5L TM (p = 0.007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11.2 points; p = 0.031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (p < 0.050). Overall, NMES compliance exceeded 95%. CONCLUSION: Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. REGISTRATION NUMBER: Trial 1 NCT02436200; trial 2 NCT02429310 (http://www.ClinicalTrials.gov).

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