Immediate Versus Early Endovenous Ablation In Venous Ulcer

Oulu University Hospital

Status: Completed

Conditions: Venous Ulcer

Treatments: Procedure: Endothermal ablation; Procedure: Foam sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03795064

268/2018

Details and patient eligibility

About

The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

Full description

Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Venous ulcer > 1 month
• Ulcer area > 1cm2
• Palpable distal pulses / Ankle-brachial index > 0,8 / Toe-brachial index > 70mmhg (at least one criteria must be met)

Exclusion criteria

• Leg ulcers other than venous etiology
• Pregnancy
• General contraindications for foam sclerotherapy
• Ulcers requiring operation theater revision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).

Treatment:

Procedure: Endothermal ablation

Procedure: Foam sclerotherapy

Early Intervention

Active Comparator group

Description:

Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).

Treatment:

Procedure: Endothermal ablation

Procedure: Foam sclerotherapy