The time course for data collection and follow-up
Study period | Enrolment and allocation | Follow-up | |||||
Time point | Screening (−14~0 day) | Allocation (0 day) | 7 days (±3 days) | 1 month (±7 days) | 3 months (±15 days) | 6 months (±30 days) | 12 months (±30 days) |
Informed consent | X | ||||||
Demographics | X | ||||||
Allocation | X | ||||||
Vital signs | X | X | X | X | X | X | |
Previous medical history | X | ||||||
Inclusion/exclusion assessment | X | ||||||
Routine blood | X | X | |||||
Blood biochemistry | X | X | |||||
Pregnancy check | X | ||||||
Blood coagulation function | X | ||||||
D-dimer | X | ||||||
ECG | X | ||||||
Doppler ultrasonography of lower extremity vein | X | X | X | X | X | X | |
VCSS | X | X | X | X | X | ||
AVVQ | X | X | X | X | X | ||
Instrument performance evaluation | X | ||||||
Drug use | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X |
AVVQ, Aberdeen Varicose Vein Questionnaire; VCSS, Venous Clinical Severity Score.