A randomized controlled trial of 3% polidocanol foam with saline prewashing compared with standard foam sclerotherapy for the treatment of varicose veins

BACKGROUND: Chronic venous disease is a highly prevalent global condition. Sclerotherapy with polidocanol foam is an established minimally invasive treatment. However, complications such as postprocedural hyperpigmentation remain common, and the maximum injectable volume per session may limit treatment efficacy. These factors highlight the need for optimized techniques to enhance vein occlusion and cosmetic outcomes. This study evaluated the efficacy and safety of 3% polidocanol foam with prewashing with saline compared with the conventional 1% polidocanol foam method. METHODS: This single-center, prospective, randomized controlled trial enrolled 35 patients (70 limbs) with Clinical Ethological Anatomical Pathophysiological class C2 to C5 varicose veins. Participants were randomized 1:1 to receive either 3% polidocanol foam with 0.9% saline prewashing and extrinsic compression using a low-density polyethylene cylinder at 20 to 30 mm Hg, or 1% polidocanol foam. Primary outcomes were venous occlusion at day 90 on Doppler ultrasound examination and foam volume. Secondary outcomes were superficial venous thrombosis, hyperpigmentation, and quality of life, assessed using the revised Venous Clinical Score at baseline and day 90. RESULTS: Thirty-one patients (62 limbs) completed the study (16 in the 3% polidocanol plus saline prewashing group; 15 in the 1% polidocanol group). Baseline characteristics were comparable across treatment arms. No major adverse events occurred. Occlusion rates were similar between the groups (P = .80). The 3% polidocanol foam technique achieved comparable occlusion using significantly less foam volume (0.27 ± 0.21 mL vs 0.54 ± 0.28 mL; P < .001). Rates of superficial thrombosis and hyperpigmentation were low and did not differ significantly. No statistically significant difference in the revised Venous Clinical Score was observed between groups; the small sample size may limit interpretation of these findings. CONCLUSIONS: The 3% SALFOAM method can be used with comparable efficacy and safety while using a lower sclerosant volume.