Background: the management of chronic venous disease is based on the targeted treatment of the arch of the foot and the gait. Epitact ® Light Legs phlebological insoles is a medical device designed to stimulate and optimize venous return in patients with chronic venous disease.

Method: Semell’Innov is a prospective, randomized controlled, two-arm single center study. The goal was to measure the impact of insoles on symptoms (VEINES-QOL/Sym) and quality of life (CIVIQ14) in patients with stage C2S chronic venous disease (CEAP classification - Clinical C, Etiological E, Anatomical A, and Pathophysiological P). 46 subjects were evaluated for two months, during which they randomly used either their usual non-phlebological insoles or phlebological insoles.

Result: our data showed that wearing phlebological insoles led to a reduction in symptoms. (VEINES-QOL/Sym score - inclusion visit: 35.6 ± 6.9; usual non-phlebological insoles: 38.7 ± 6.5; phlebological insoles: 45.1 ± 5.5; p<0.001) and improved quality of life (CIVIQ14 score - inclusion visit: 19.8 ± 16.3; usual non-phlebological insoles: 13.9 ± 12.6; phlebological insoles: 8.0 ± 11.1; p<0.001).

Conclusion: these results suggest that the use of the Epitact ® Light Legs phlebological insoles may have a beneficial effect on the symptoms and quality of life of patients with chronic venous disease.