Effects of a new nutraceutical substance on clinical and molecular parameters in patients with chronic venous ulceration

Pathophysiological events involved in the onset of chronic venous ulceration (CVU) are inflammation, activation of polymorphonucleates (PMNs) and secretion of proteases such as matrix metalloproteinases (MMPs), which degrade extracellular matrix (ECM) that is a support for vascular and tissutal wall. MMPs, neutrophil gelatinase-associated lipocalin (NGAL) and inflammatory cytokines are overexpressed in CVUs and they could play a central role in pathophysiological mechanisms of skin lesion and delayed wound healing. Bioflavonoids, such as diosmin and other compounds, appear to have several provessel function activities including anti-inflammatory, antioxidant and phlebotonic effects and are widely used in the treatment of chronic venous disease (CVD)-related problems. In this article, we evaluated the effects of Axaven (R), a new nutraceutical on both clinical and molecular parameters in patients with CVUs. During the study period, 83 patients with CVUs of both sexes were enrolled and divided into two groups: group A (treated group): 25 females and 19 males (median age is 67.7 years) received standard treatment (compression therapy and surgical correction of superficial venous incompetence) + Axaven (R) once a day for 8 months as adjunctive treatment. Group B (control group): 24 females and 15 males (median age is 65.2 years) were treated only with basic treatment according to their clinical conditions. In our study, the administration of Axaven (R) in patients with CVUs was able to decrease inflammatory cytokines, MMPs and NGAL, inducing an improvement of both symptoms with an increase of the speed of wound healing. [Correction added on 20 March 2015, after first online publication: The number of patients, 36 patients (Group A: 9 females and 7 males; Group B 11 females and 9 males) were wrong and have been changed to 83 patients (Group A: 25 females and 19 males; Group B: 24 females and 15 males) in the abstract.]