Effects of topical ozonated olive oil on lipid profile, quality of life, wound healing and glycemic control in patients with diabetic foot ulcers: a randomized controlled trial.
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INTRODUCTION: Diabetic foot ulcers (DFUs) are a severe complication of diabetes, leading to infections, amputations, and reduced quality of life. Ozonated olive oil, combining ozone's antimicrobial properties with olive oil's biocompatibility, shows promise in chronic wound management. Limited evidence exists on its comprehensive effects in DFUs. This study evaluates its impact on wound healing, quality of life, glycemic control, lipid profiles, and inflammation. METHODS: A randomized controlled trial was conducted at a tertiary care center in Hormozgan Province (January-December 2024) with 123 adults (aged 18-75) with type-2 diabetes and Wagner grade 1-2 DFUs. Participants were randomized (1:1) to receive daily topical ozonated olive oil (50 g/m³, 5 mL) or standard care for 4 weeks. Outcomes included wound severity (Bates-Jensen Wound Assessment Tool [BWAT]), quality of life (Diabetes Quality of Life Questionnaire [DQOL]), glycemic control (Glycated Hemoglobin [HbA1c], Fasting Blood Glucose [FBG], Postprandial Glucose [PPG]), lipid profiles (Low-Density Lipoprotein [LDL], High-Density Lipoprotein [HDL], Triglycerides [TG], Total Cholesterol), and inflammatory markers (High-Sensitivity C-Reactive Protein [hs-CRP], Interleukin-6 [IL-6], Tumor Necrosis Factor-alpha [TNF-α]). Assessments occurred at baseline, post-intervention, and 4 weeks post-intervention. Linear Mixed Models (LMM) and Analysis of Covariance (ANCOVA) analyzed outcomes, adjusting for baseline values. RESULTS: The intervention group (n = 62) showed significant improvements compared to controls (n = 61). Bates-Jensen scores decreased (22.3 ± 4.5 vs. 26.1 ± 4.9, p < 0.001, Cohen's d = 0.67) at 4 weeks post-intervention, indicating better wound healing. Quality of life scores improved (50.1 ± 9.5 vs. 57.8 ± 10.0, p < 0.001, Cohen's d = 0.72). HbA1c reduced (7.1 ± 1.0% vs. 7.7 ± 1.1%, p = 0.005, Cohen's d = 0.51), as did fasting (145.3 ± 22.5 vs. 158.7 ± 23.9 mg/dL, p = 0.015) and postprandial glucose (190.1 ± 31.5 vs. 210.2 ± 33.8 mg/dL, p = 0.009). Also, hs-CRP levels dropped (2.9 ± 1.0 vs. 3.6 ± 1.1 mg/L, p = 0.006, Cohen's d = 0.50), but IL-6/TNF-α and lipid profiles showed no significant changes (p > 0.05). CONCLUSION: Topical ozonated olive oil significantly enhances wound healing, quality of life, glycemic control, and reduces inflammation in DFU patients. Its affordability and efficacy make it a promising adjunctive therapy. Further studies should explore long-term effects and mechanisms. It offers a scalable solution for DFU management.