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Ozone Gas Bath Combined with Endovenous Laser Therapy for Lower Limb Venous Ulcers: A Randomized Clinical Trial

ABSTRACT Background: Endovenous laser therapy (EVLT) is safe and effective for lower limb venous ulcers. However, severe necrosis and infection in the ulcer area are contraindications of puncture and EVLT. Local bath with ozone gas has been shown to improve the condition of ulcer areas. The aim of this study was to evaluate the clinical efficacy of ozone gas bath combined with EVLT in comparison with EVLT alone for the treatment for lower limb venous ulcers. Patients and Methods: Ninety-two patients with venous ulcers were randomized to receive ozone gas bath combined with EVLT (OEVLT group) or EVLT alone (EVLT group). In the OEVLT group, the venous ulcers were preconditioned with ozone gas bath prior to EVLT. The minimum follow-up time was 12 months. The two groups were compared in terms of complete occlusion of the treated veins, ulcer healing ratio, ratio of ulcer recurrence, patient satisfaction, complications, and side effects. Results: There was no significant difference in venous occlusion between the two groups. The ratio of ulcer healing in the OEVLT group was significantly higher than the EVLT group at 12 months follow-up. Patients in the OEVLT group showed better satisfaction and a lower recurrence ratio than the OEVLT group. No severe complications or side effects occurred in either groups. Conclusions: Ozone gas bath combined with EVLT showed improved efficacy for the treatment of lower limb venous ulcers and lower recurrence ratio comparison with EVLT alone. This procedure is a safe and technically feasible.