Abstract
INTRODUCTION: The progression of chronic venous disease (CVD) is characterized by edema of the legs and/or venous ulcers of the lower limbs in association with cutaneous signs and/or skin alterations, such as hyperpigmentation, corona phlebectatica, telangiectasia, eczematous dermatitis, lipodermatosclerosis, atrophie blanche, cellulitis, and induration. Xioglican cream is a galactosaminoglycan polysulfate and hyaluronic acid-containing medical device with strong hydrophilic, moisturizing, and soothing properties. This post-marketing observational study evaluated topical Xioglican cream in the amelioration of skin manifestations and clinical signs and symptoms in patients with CVD treated in routine clinical practice. METHODS: Adult patients (18-75 years) with a clinical diagnosis of C2-C3 CVD according to Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification who received 12 weeks of treatment with Xioglican (applied up to 3 times daily), according to investigator decision (and consistent with conventional clinical practice and established standard of care), were enrolled from two study sites in Italy. A range of endpoints were used to evaluate efficacy, safety, effect on patient quality of life (QoL), and patient satisfaction with topical application of Xioglican cream in the physiological restoration of skin signs and symptoms. RESULTS: In patients with CVD (n = 30), Xioglican cream reduced CVD-related skin manifestations and associated symptoms, with significant reductions in leg circumference [mean ± standard deviation (SD): - 3.21 ± 3.39 cm for left and - 2.92 ± 2.70 cm for right legs, both p < 0.0001] and local edema (- 5.52 ± 7.94 cm, p = 0.0034) and significant improvement in Venous Clinical Severity Scores (mean 0.52 ± 1.94 decrease from baseline, p = 0.1952) observed after 12 weeks. Skin burning, pain, aching or tiredness, and QoL were also significantly improved. There was no change in CEAP classification. Globally, 92.0% of patients were "Very satisfied" or "Satisfied" with the product. CONCLUSIONS: Topical treatment with Xioglican cream improves the signs, symptoms, and QoL of patients with CVD class C2-C3.