Efficacy of local ozone therapy for the treatment of digital ulcers refractory to medical therapy in systemic sclerosis: A randomized controlled study.

Objective: Reynoud phenomenon (RP) and digital ulcers (DUs) negatively affect hand functions and quality of life in patients with systemic sclerosis (SSc). The aim of this study was to investigate the efficacy of ozone therapy in SSc patients with DUs resistant to medical therapy. Methods: The participants' demographic data, medical treatment, organ involvement, and clinical parameters (duration and number of RP attacks, ulcer pain and diameter) were recorded. Twentyfive SSc patients with DU were randomized to the ozone group (I) (n=13) treated with medical treatment plus oxygen-ozone therapy and the control group (II) (n=12) treated with medical treatment only. The efficacy of the treatment was evaluated using the scale. Hand functions were assessed with 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 at the end of the treatment. Results: There was no statistically significant difference between the ozone and control groups in terms of clinical and demographic data. At the end of the month, the effective healing rate was significantly higher in group (I) than in group (II), where it represented 92% in ozone group versus 42% in control group (p=0.010). Morever, ulcer size, ulcer pain, duration and number of RP attacks, HAQ, and HAMISm scores were significantly improved in the treatment group compared to the control group (p<0.05). Conclusion: Local ozone therapy is effective in the treatment of resistant DUs in SSc patients and improves clinical parameters and functional disability. [ABSTRACT FROM AUTHOR]