Investigating the Therapeutic Effect of Ozone Therapy Combined with Alginate Compared to Alginate Alone on the Wounds of Patients with Diabetes: A Three-blind, Randomized, Multicenter Clinical Trial with a Control Group

Introduction: Diabetes is one of the most common non-infectious diseases, and diabetic foot ulcers are one of the most common and debilitating complications, so that every ۳۰ seconds, a person in the world loses their lower limb due to diabetic foot ulcers. Today, there are various methods for treating diabetic foot ulcers, one of which is ozone therapy. Ozone has antibacterial and antioxidant properties and can prevent free radical damage and cause healing effects in wound healing. Ozone can create antibacterial properties by destroying the bacterial cell membrane. In addition, ozone has anti-inflammatory properties and inhibits the migration of mast cells. For the treatment of diabetic wounds, an effective method is needed that shortens the treatment period and, at the same time, has an acceptable cost. Due to the antioxidant, anti-inflammatory, and antibacterial properties mentioned in the studies for the ozone therapy method and the lack of toxicity and side effects for patients, This study was conducted with the aim of investigating the therapeutic effect of ozone therapy combined with alginate compared to alginate alone on the wounds of patients with diabetes.Methods: In this randomized clinical trial, ۲۰۰ people aged ۱۸ to ۸۰ who were suffering from diabetes and whose wounds were in the ۲nd or ۳rd grade of the Wagner scale participated. Also, their ankle-brachial scale was between ۰.۷ and ۱.۲, the wound was not contaminated or infected, the debridement wound was free of necrosis and sinus tracts, and its area was between ۱ and ۲۵ square centimeters. Also, the hemoglobin A۱C level of the participants was less than ۱۲%. After the initial screening, the participants were randomized into two groups, A and B, in a three-way blind manner. The duration of this course was ۱۰ sessions, which were conducted twice a week (Sundays and Wednesdays). In group A, in addition to alginate dressing, the participants were subjected to ozone therapy (Device of Sefidjamgan Technologies Company) in the first ۳ sessions with ۱۰۱ settings for ۲۰ minutes, and if the wound did not heal, alginate dressing was used until granulation tissue formation. After that, foam dressing is used until complete epithelialization. In patient B, alginate dressing in the form of Tabagran Trita powder has been used for ۱۰ sessions. Standard interventions for diabetic foot ulcers include periodic visits and taking digital photos of the wound, which were done to monitor the basic evaluations

کلیدواژه ها:

ozone therapy ، alginate ، wound