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

ABSTRACT

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 toe-brachial indices, transcutaneous oxygen pressure (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 +/- 33 m and increased to 277 +/- 67 m, after the treatment session (P = 0.004). Mean maximal walking distance was 213 +/- 37 m and it increased to 603 +/- 77 m (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 degrees 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.