In a study conducted in Guatemala and Venezuela in the years 2015-2016 the effectiveness of Sildenafil Maleate vs conventional treatment were compared in patients with diabetic foot Wagner 2 and Wagner 3, and it was shown that patients who received 10g of Sildenafil Maleate daily had a greater granulation effectiveness and speed as well as healing, making it an effective and safe medication since no adverse effects were seen in any of the patients.

Endothelial dysfunction (ED) is common in diabetic patients. It is defined as an abnormal response that leads to a decreased nitric oxide (NO) bioavailability and consequent in vasodilation alteration. ED represents a risk factor that is strongly associated with the occurrence of vasculopathy. Sildenafil Maleate specifically inhibits phosphodiesterase 5 (PDE5), which leads to an increased NO bioavailability, and a significant reduction in vascular inflammation markers such as C-reactive protein, interleukin-6, endothelin-1, VCAM (vascular adhesion molecule) and ICAM (intercellular adhesion molecule), improving endothelial function and consequently vasodilation, microcirculation, decreasing granulation time and helping heal diabetic foot ulcers, evolution time and treatment costs, as well as the psychological impact and risk of amputation.