The Effect of Nurse-Led Intervention on the Healing of Diabetic Foot Ulcers With Ozonated Olive Oil: A Randomized Controlled Trial Publisher



Niasar AA¹ ; Abdi F² ; Jandaghianbidgoli M³ ; Amirdehi MA³ ; Bahrami T³ ; Khanchemehr Y⁴ ; Yaghobi M⁵ ; Safa A⁶ Show Affiliations
Source: Journal of Nursing and Midwifery Sciences Published:2025

Abstract

Background: Diabetic foot ulcers (DFUs) are a common and challenging complication of diabetes, often requiring prolonged and complex treatments. Innovative and effective therapies are crucial for improving wound healing. Ozonated olive oil, with its potential anti-inflammatory and antioxidant properties, may offer a promising alternative for wound management. Objectives: The objective of this randomized controlled trial is to evaluate the effect of ozonated olive oil on the healing of DFUs. Methods: This study employed a prospective, randomized, controlled trial design with a parallel-group setup from July 20 to September 1, 2023, at a private outpatient clinic. Participants, aged 18-75 with type 1 or type 2 diabetes and DFUs, were randomly assigned to either a control or intervention group. The control group received standard wound care, while the intervention group had ozonated olive oil applied. The outcomes included wound healing, assessed using the Wagner wound classification and a checklist for evaluating the healing progress of DFUs. Statistical analysis was performed using SPSS version 22, with significance set at P ≤ 0.05. Results: The average age of participants in the intervention group was 58.33 years ± 6.13, while the control group had an average age of 63.80 ± 6.53. In this study, comparisons between the intervention and control groups revealed no significant differences in gender, marital status, employment status, or other similar demographic variables (P > 0.05). After a 4-week intervention, the wound degree (75.1389 ± 8.74121), color (46.714 ± 10.77), surrounding tissue condition (70.55 ± 7.346), and wound healing status (P < 0.001) were significantly improved after week 4 in the intervention group. The analysis showed that the intervention group consistently demonstrated higher effect sizes compared to the control group in terms of overall wound characteristics, with the intervention group’s 95% confidence interval ranging from 180.649 at baseline to 311.912 at time point 4, while the control group’s 95% confidence interval ranged from 179.856 to 214.469 (effect size of 0.878 for the intervention and 0.02 for the control group). Conclusions: Our study underscores the pivotal role of ozonated olive oil in the management of DFUs. Such nurse-led interventions can significantly accelerate wound healing. This highlights the potential of nursing-centered care models in optimizing outcomes for patients with chronic wounds. Future research should explore the long-term benefits of the intervention and its applicability to diverse populations. © 2025, Abasi Niasar et al.