Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-03-31

Brief Summary

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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)

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Detailed Description

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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

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Compression

Patients in this group will not receive any compression after treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Compression

Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).

Group Type ACTIVE_COMPARATOR

Class II Compression Stockings

Intervention Type DEVICE

Interventions

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Class II Compression Stockings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
* Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
* Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation