Intermittent Ozone Insufflation as an Adjuvant Therapy for Ischemic Ulcers in Lower Extremity Arterial Occlusive Disease: A Prospective Randomized Controlled Study

Background: Lower extremity arterial occlusive disease (LEAOD), primarily arteriosclerosis obliterans (ASO), often leads to chronic, refractory ischemic ulcers, posing significant challenges in wound management and carrying high risks of amputation and mortality. This study aimed to evaluate the clinical efficacy and safety of intermittent local ozone insufflation as an adjuvant therapy for promoting wound healing and alleviating pain in patients with ASO-related ischemic ulcers. Methods: In this prospective randomized controlled trial, 62 eligible patients with LEAOD and lower limb ulcers admitted between July 2023 and December 2024 were randomly assigned to either an experimental group (n=32) or a control group (n=30). The control group received standard wound care (debridement, dressing changes), while the experimental group received standard care plus twice-daily local ozone insufflation (50 ml per session, 20 minutes each). Wound pain (Visual Analog Scale, VAS) and wound status (Bates-Jensen Wound Assessment Tool, BWAT) were assessed before intervention and on days 1, 3, and 7 post-intervention. Results: It showed that the experimental group had significantly lower VAS scores than the control group post-intervention (P