Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
Changes from baseline in the resting flux
measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry
Time frame: Baseline, after 6 weeks of treatment
Changes from baseline in the resting flux
measured in the frequency range 10-37 kHz
Time frame: Baseline, after 3 weeks of treatment
Changes in the resting flux
measured in the frequency range \<10 kHz
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the combined resting fluxes (<37 kHz)
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the transcutaneous oximetry (TcPO2)
measured on the inside lower leg of the more CVI-affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the calf circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the ankle circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Time frame: Baseline, after 3 and 6 weeks of treatment
Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: after 6 weeks of treatment
Global efficacy assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients with clinically relevant changes in laboratory values
Time frame: Baseline, up to 16 weeks
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, up to 16 weeks
Global tolerability assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Global tolerability assessment by patient on a 4-point VRS
Time frame: after 6 weeks of treatment