Enrollment visit |
• The nurse completes the baseline form (inclusion/exclusion criteria, demographic and clinical variables, results of objective tests for DVT), PTS scale and pain scale |
• The patient self-completes the QOL form |
• The nurse performs the leg measurements to size the stockings |
• The nurse teaches patients how to apply (using a plastic leg model) and care for stockings (handling, washing), and reinforces the importance of daily use |
• Study stockings are supplied to the patient (within a few days after enrollment) |
• A venous blood sample is taken for markers of inflammation |
2-week telephone call |
• The nurse reinforces the importance of wearing stockings daily |
• Bleeding/Other Adverse Event form and pain scale are completed |
For the following visits, the patient does not wear study stocking to prevent unblinding of study nurse: |
1-month visit |
• The nurse completes the follow-up form (includes data on symptoms and signs of PTS, suspected recurrent VTE, compliance with stockings, pain scale) |
• The patient self-completes the QOL form |
• Bleeding/Other Serious Adverse Event form is completed |
• A venous blood sample is taken for markers of inflammation and genetic thrombophilia |
• The nurse reinforces the importance of wearing stockings daily |
2-month telephone call |
• Same as the 2-week telephone call |
6-month visit |
• The nurse completes the follow-up form |
• The patient self-completes the QOL form |
• Bleeding/Other Serious Adverse Event form is completed |
• Leg measurements are taken, and a new pair of stockings is supplied |
• A venous blood sample is taken for markers of inflammation, d-dimer and coagulation-based assays |
• The nurse reinforces the importance of wearing stockings daily |
1-year visit |
• Same as 6-month visit except no blood sampling |
• A venous ultrasound is performed to assess reflux |
18-month visit |
• Same as 6-month visit except no blood sampling |
2-year visit |
• The nurse completes the follow-up form |
• The patient self-completes the QOL form |
• Bleeding/Other Serious Adverse Event form is completed |
• The success of blinding (patient, nurse, and investigator) is assessed (or at Study Termination if earlier than 2 years). |