NCT02890563

Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)

Detailed description

In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group. Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage. Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DEVICE	Class II Compression Stockings

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-09-07
• Last updated: 2019-04-01

Locations

2 sites across 1 country: Finland