Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Imperial College London

Status and phase: Enrolling; Phase 4

Conditions: Varicose Veins

Treatments: Procedure: Ambulatory phlebectomy; Drug: Foam sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03416413

17/WS/0192

Details and patient eligibility

About

This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.

The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 18 years of age
• Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
• Varicose vein tributary requiring treatment

Exclusion criteria

• Current DVT
• Recurrent varicose veins
• Arterial disease (ABPI<0.8)
• Vein diameter < 3mm
• Preference for one of the treatment options
• Patient who are unwilling to participate
• Inability or unwillingness to complete questionnaires
• Inability to attend follow-up appointments
• Patient currently included in a study of varicose vein treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Ambulatory Phlebectomy

Active Comparator group

Description:

Ambulatory phlebectomy of varicose vein tributaries

Treatment:

Procedure: Ambulatory phlebectomy

Foam Sclerotherapy

Active Comparator group

Description:

Injection of foam sclerosant into varicose vein tributaries

Treatment:

Drug: Foam sclerotherapy