The effect of topical olive oil on the healing of foot ulcer in patients with type 2 diabetes: a double-blind randomized clinical trial study in Iran.

Background: Diabetic Foot Ulcer (DFU) is the most costly and devastating complication of diabetes mellitus which can lead to infection, gangrene, amputation, and even death if the necessary care is not provided. Nowadays, some herbal products have shown therapeutic effects on healing of DFU. So, this study aimed to assess the effects of topical olive oil on the healing of DFU.
Methods: This double-blind randomized clinical trial study was conducted in Diabetes Clinic of Ahvaz Golestan hospital, Iran, in 2014. Thirty-four patients with DFU of Wagner's ulcer grade 1 or 2 were enrolled in this study. Patients who were randomly assigned to intervention group (n = 17) received topical olive oil in addition to routine cares, whereas patients in control group (n = 17) just received routine cares. Intervention was done once a day for 4 weeks in both groups, and in the end of each week; the ulcers were assessed and scored. Data was collected by demographic and clinical characteristics checklists as well as diabetic foot ulcer healing checklist, and was analyzed by SPSS version 19 software using descriptive (mean and standard deviation) and analytic (student's sample t-test, chi-square and repeated-measures analysis of variance) statistics.
Results: At the end of 4(th) week, there was a significant differences between two groups regarding to 3 parameters of ulcer including degree (P = 0.03), color (P = 0.04) and surrounding tissues (P < 0.001) as well as total status of ulcer (P = 0.001), while related to ulcer drainages no significant difference was seen between the two groups (P = 0.072). At the end of the follow up, olive oil significantly decreased ulcer area (P = 0.01) and depth (P = 0.02) compared with control group. Complete ulcer healing in the intervention group was significantly greater than control group (73.3% vs. 13.3%, P = 0.003) at the end of follow up. Also, there were no adverse effects to report during the study in intervention group.
Conclusions: Our results indicated that olive oil in combination with routine cares is more effective than routine cares alone, and is without any side effect. However, further studies are required in the future to confirm these results.
Trial Registration: IRCT2014083014251N2.