Abstract
Objective: The aim of the study was to show whether silver fibres interwoven into regular compression stockings will enhance the nutritive capillary perfusion in chronic venous insufficiency (CVI) patients.
Methods: Double-blind, randomized crossover trial with two 10-day treatment phases and an intermediate three-day wash-out in 20 CVI patients (7 males, 13 females, median age: 65 years), comparing regular and silver fibres containing class II compression stockings. Primary endpoint: tcpO2 measurement at 44°C probe temperature in the peri-malleolar region of the reference leg.
Results: In the overall study population, the 'end-of-treatment-phase' minus 'start-of-treatment-phase' tcpO2 – differences were negative for the regular hosiery (median [MAD]: -6.75 [8.5] mmHg, supine leg position; -7.25 [5.75] mmHg, dependent leg position), but positive for the silver fibre containing fabric (median [MAD]: 4.0 [7.75] and 2.5 [8.5] mmHg for the supine and the dependent leg position). The intergroup differences in the overall data were not statistically significant. Analysis of a core data-set, excluding data points above the 90% and below the 10% percentile, approached (P = 0.052, supine) or reached statistical significance (P = 0.023, dependent leg position).
Conclusions: The study provides first evidence that using interwoven silver fibres in class II compression stockings results in clinical benefit for CVI patients.
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