This study confirmed the value of the Venous Severity Score as an instrument for evaluation of chronic venous insufficiency. A significant increase in the VCSS and VSDS paralleled CEAP clinical class; VDS was higher in classes C3 and C6 without reaching significance, probably because of the small size of the samples. Some clinical and anatomic features need to be clarified to facilitate scoring.
Objective To evaluate the efficacy, safety and acceptability of an innovative two-component versus a well-established four-component compression systems in the management of venous leg ulcer. Method Multicentre randomized controlled trial in patients with active venous leg ulcer. Patients were followed-up monthly for a maximum of 16 weeks. The primary endpoint was the complete healing rate at 16 weeks. Results Ninety-two patients were randomized to either the two-component BIFLEX® Kit group ( n = 49) or the four-component PROFORE® group ( n = 43). In the full analysis set ( n = 88), a complete healing rate of 48.9% and 24.4% was reported in BIFLEX® Kit versus PROFORE® groups, respectively (i.e. a superiority of 24.5%, p = 0.02). Acceptability of BIFLEX® Kit was higher from both the patients’ and physicians’ perspectives. Conclusion The BIFLEX® Kit represents a valid alternative therapy in the management of venous leg ulcer according to its clinical efficacy, safety and acceptability with potential positive impacts on healthcare costs.
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