Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.
• Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: \>0.5 seconds (s) in the superficial venous system, or \> 1.0 s in the deep system, or \> 0.35 s in a perforator vein.