[Booster study: comparative evaluation of a new concept of elastic stockings in mild venous insufficiency]
Abstract
BACKGROUND: Evaluate a new progressive concept of compression stockings in comparison with degressive compression stockings class 2 in patients with mild venous insufficiency without permanent oedema (class 1 of Porter's classification or C0s-C1s-C2s CEAP's classification). METHODS: The aim of this randomised, double-blind french, multicenter trial was to compare the efficacy and convenience of the new ES compared to conventional ES in patients with mild venous insufficiency for whom elastic compression by knee stockings was indicated. The primary endpoint was leg heaviness after 15 days of wearing ES. Secondary endpoints were discomfort and compliance. RESULTS: A total of 130 patients were included (progressive ES: 64; conventional ES: 66). Mean age was 43 years, 68% were women. Disappearance or major improvement of leg heaviness was observed in 73% of patients wearing progressive ES and 62.5% of those wearing conventional ES (difference = -10.5% [95% CI -26.7; +5.6]). This result met pre-specified statistical criteria for non-inferiority and was confirmed by per-protocol analysis. Ease of putting on ES and comfort were significantly better with progressive ES (p<0.0001), as was compliance (p=0.016). INTERPRETATION AND CONCLUSIONS: The Booster study is the first randomised, double-blind, multicentre trial evaluating a new concept of compression in mild venous insufficiency. The progressive ES is as efficient as degressive ES but it observance is better. This promising new concept deserves to be evaluated in other settings.