Prospective Comparative Observational Study of Safety and Efficacy of Topical Ozone Gas Therapy in Healing of Diabetic Foot Ulcers versus Only Conventional Wound Management.

Abstract

The prevalence of diabetic foot ulcers (DFUs) in India is 11.6%. DFU accounts for major cost expenditure, morbidity, and mortality. 1 Ozone gas has antimicrobial and antioxidant properties. We studied efficacy of topical ozone gas therapy in promoting healing of DFU. This is an observational comparative cohort study, n = 160, There were two groups of patients namely: those who received Conventional wound management alone C and those who received topical ozone therapy in addition to conventional wound management O + C therapy groups (81 each). Study group, i.e., O + C received five alternate day sessions of ozone therapy by bagging method for 30 minutes each session. Both groups were observed for 30 days for wound healing parameters like reduction of wound surface area, wound diameter, presence and character of discharge, granulation tissue, healing wound edges, microbial negativity, and requirement of revision (re-debridement and/or amputation) surgery. Mean baseline ulcer surface area is 17.43 ± 8.6 cm 2 for C and 17.87 ± 9.2 cm 2 (range 1–50 cm 2 ) in O + C group. Percentage change in ulcer surface after 21 days in O + C group is 32.37% compared with 17.15% in C group, which is statistically significant ( p = 0.01). Rates of microbial negativity and ulcer healing were significantly faster in ozone group. There was a statistically significant decrease in hospital stay, number of revision surgeries required, and mortality in ozone group. Topical ozone gas was well tolerated. Our study supports the efficacy of ozone therapy in DFU healing and reduction in the chances of infection and revision (re-debridement and/or amputation) surgery. More research is needed for dose, duration, and exposure time standardization.