Assessment of a topical product based on polysulfated galactosaminoglycan as an adjuvant in the treatment of acute STP and stasis dermo-hypodermitis.

Abstract

Superficial thrombophlebitis (STP) is a relatively frequent pathology characterized by possible extension to the deep venous circulation, with notable local inflammatory reaction which is treated by subcutaneous administration of Fondaparinux. Stasis dermo-hypodermitis is characterized by cutaneous hyperpigmentation and eczema, treatment for which consists of the use of drugs targeting endothelial cells (mesoglycan, FFPM, sulodexide). In this study we evaluated the impact of local application of a mixture of semi-synthetic polysulfated galactosaminoglycans on the regression rate of STP and dermo-hypodermitis in patients treated with best medical therapy (BMT). Thirty patients (20 F and 10 M) were enrolled from May to December 2017, 20 with dermo-hypodermitis due to stasis secondary to post-thrombotic syndrome (PTS) and 10 with acute STP of the great saphenous vein or its collaterals. Topical administration of the galactosaminoglycan-based product was added to the BMT of 10 pts with PTS and 5 pts with STP for 45-60 days. In all patients a Visual Analogical Scale (VAS) was used to assess the intensity of spontaneous and induced pain at 0, 15, 30, 45 and 60 days. With regard to PTS, VAS values at time 0 were comparable between the two groups, while at later times there was a progressive reduction in the score, with values of ≤2 at 30 days for patients treated with the topical product based on galactosaminoglycans vs. 60 days for the other control subjects. With regard to STP, the values of VAS at time 0 between the two groups were comparable, while at time 15 the VAS value was lower in subjects treated with the topical product. This pilot study on the efficacy of a local formulation of a mixture of semi-synthetic polysulfated galactosaminoglycans highlighted the role of this product in accelerating the recovery of patients at the most advanced stages of chronic venous disease (CVD) and in the management of its complications. In the future, studies of larger series will be needed with the use of placebo to substantiate their effectiveness in these conditions and in other classes of CVD.