Efficacy of Local Oxygen-Ozone Therapy for the Treatment of Digital Ulcers Refractory to Medical Therapy in Systemic Sclerosis: A Randomized Controlled Study
Abstract Background This study aimed to investigate the efficacy of local oxygen-ozone therapy in systemic sclerosis (SSc) patients with digital ulcers (DUs) who were resistant to medical therapy and had impairment in activities of daily living. Methods Participants’ demographic data, medical treatment, and clinical parameters (duration and number of Reynaud’s Phenomenon (RP) attacks, ulcer pain, grade, and diameter) were recorded. Twenty-five SSc patients with DUs were randomized to the ozone group (I) (n = 13) to receive medical treatment plus local oxygen-ozone therapy and the control group (II) (n = 12) to receive medical treatment only. Hand functions were assessed using the Health Assessment Questionnaire (HAQ) and Modified Hand Mobility in Scleroderma (HAMISm) test. Ulcer grade, clinical parameters, HAQ, mHAMIS scores were re-evaluated in all participants 4 weeks after the initiation of treatment. Results Demographic and clinical characteristics of the two groups showed no significant differences. At 4 weeks after the initial treatment, the efficacy rate was significantly higher in the ozone group than in the control group (92% versus 42%, p = 0.010). Clinical parameters, HAQ, and HAMISm scores were significantly improved in the treatment group compared to the control group (p < 0.05). Conclusion Local oxygen-ozone therapy was effective in the treatment of SSc patients with resistant DUs and improved clinical parameters and functional disability.