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 cm2 for C and 17.87 ± 9.2 cm2 (range 1–50 cm2) 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.

Physical Treatment of Diabetic Foot Ulcers—Preliminary Study for Topical Application of Oxygen or Ozone Auxiliary Treatment of Diabetic Foot Ulcers

“…Te mean healing time was 69.44 ± 36.05 days (range 15-180 days) [32]. Te previous observations are also consistent with the results of the studies by Dhamnaskar et al [33].…”

“…In turn Dhamnaskar S. et al reported that topical ozone gas therapy causes indirectly decrease of overall costs of treatment of patients with DFU as compared to the conventional management, mainly due to the faster rate of ulcer healing and early microbial negativity, resulting in reduction of duration of hospital stay and reduction in requirement of revision surgery [33].…”

Hypochlorous acid in a double formulation (liquid plus gel) is a key prognostic factor for healing and absence of infection in chronic ulcers. A nonrandomized concurrent treatment study

“…In some ulcers, especially those of vascular origin, the above treatment would be accompanied by the noninvasive application of ozone, as has been done in other studies. 21 If the wound is healing well, cures are scheduled approximately every 2 days until complete healing, or until voluntary discharge, Note: Percentages in relation to the total of the respective column.…”

Ozone therapy for skin diseases: Cellular and molecular mechanisms

“…Ozone therapy has been widely used in more than 50 pathological processes, including skin diseases, intervertebral disc herniation, 4 diabetic complications, 5 oral mucosal diseases, cardiovascular and cerebrovascular diseases, 6 and cancer. In terms of skin diseases, topical ozone therapy can be employed to treat infectious skin diseases (e.g., tinea capitis and herpes zoster), 7,8 inflammatory skin diseases (e.g., eczema, psoriasis, atopic dermatitis, and contact dermatitis), 9‐11 autoimmune‐related skin diseases (e.g., pemphigus, bullous pemphigoid, and dermatomyositis) 12,13 and chronic ulcers (e.g., diabetic foot and pressure ulcers) 14,15 . In addition, ozone therapy can be used to clean burns and scald wounds, 16 accelerate wound healing, 17 and promote skin repair after laser cosmetology.…”