Preprogrammed oscillations improve lower limb blood flow and walking distance in patients with peripheral arterial disease

Background: Claudication is one of the sequelae of peripheral arterial disease (PAD). To date, no effective treatment has been found for this condition. Objectives: To investigate a new device to treat PAD. The device administers pre-programmed protocols of oscillations to the foot. Methods: Fifteen patients aged 40-70 years who suffered from intermittent claudication secondary to PAD were recruited to an open prospective study. Each patient was treated once for 30 minutes. The following parameters were evaluated: pain-free and maximal walking distances, skin blood flux by laser-Doppler, skin temperature, ankle-brachial and toebrachial indices, (tcpO₂) and transcutaneous carbon dioxide pressure (tcpCO₂). Non-parametric signed-rank test was applied for testing differences between baseline assessment and post-treatment assessments for quantitative parameters. Results: Mean pain-free walking distance was 122 ± 33m and increased to 277 ± 67m, after the treatment session (P= 0.004). Mean maximal walking distance was 213 ± 37m and it increased to 603 ± 77m (P< 0.001). Foot skin perfusion also improved, as demonstrated by an increase in tcpO₂ by 28.6 ± 4.1 mmHg (P< 0.001), a decrease in tcpCO₂ by 2.8 ± 1.3(P= 0.032), and up to twofold improvement in blood flux parameters, and an increase in skin temperature by 1.9 ± 0.5°C (P< 0.001). Ankle-brachial index increased by 0.06 ± 0.01(P = 0.003) and toe-brachial index by 0.17 ± 0.02(P< 0.001). Conclusions: Preprogrammed oscillations applied to the foot had a positive effect on microcirculation, tissue oxygenation and CO₂ clearance; they had a smaller though significant effect on arterial blood pressure indices, and the change in the arterial-brachial index correlated with the change in the pain-free walking distance.