Effect of ANSIL solution on diabetic foot wounds: A double-blind clinical trial

Abstract

Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by defects in insulin secretion, insulin action, or both. Chronic hyperglycemia caused by diabetes is associated with long-term damage and dysfunction and failure of various organs, especially the eyes and kidneys. nerves, heart and blood vessels. One of the complications of diabetes that reduces the quality of life of patients and leads to amputation is peripheral neuropathy, which usually causes wounds in places that bear weight and suffers trauma due to the reduction of sense of pain. Diabetic foot ulcers that do not heal are one of the most important problems of these patients. In this project, the aim is to introduce and evaluate clinically a solution called ANSIL for healing diabetic foot ulcers, which is a combination of zinc oxide nanoparticles, silver, and plants such as milk thistle, chamomile, almond oil, and glycerin. Methods: This study was conducted as a double-blind randomized clinical trial-interventional studies with the participation of 40 patients with diabetes and foot ulcers; An information collection form was designed for the patients, where questions such as age, gender, duration of diabetes and complications caused by diabetes and smoking, wound location, wound severity based on the Texas scale, and pain intensity were recorded for the patients. Then, based on the random classification, they were divided into 4 groups of 10 people, and the patients in the first three groups received doses of 500, 1000, 2000 ppm of Ancil solution for 30 days, and the fourth group received the diabetic foot ulcer base formulation that was given in the section received the treatments used for dressing (normal saline serum). The severity of the patients' wounds was checked after 2 and 4 weeks of participating in the trial. Results: Statistical comparison between different groups showed that Ancil solution with different doses compared to each other in terms of effect on wound severity 2 weeks after the start of the intervention and 4 weeks after the intervention do not differ and are not statistically significant (p>0.05). comparing the doses of 1000 and 500 ppm compared to the placebo group in 4 weeks after the start of the intervention was not significant with a slight difference (p=0.051). The effect of Ancil with a dose of 1000 ppm on the severity of the wound 4 weeks after the treatment compared to the placebo solution is statistically significant (p=0.006).