Immediate Versus Early Endovenous Ablation In Venous Ulcer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03795064

Enrollment

Registered

2019-01-07

Start date

2018-12-05

Completion date

2023-08-30

Last updated

2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcer

Keywords

Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins

Brief summary

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

Detailed 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.

Interventions

PROCEDUREFoam sclerotherapy

Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.

PROCEDUREEndothermal ablation

Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Venous ulcer area	0 to 180 days	Venous ulcer area measured from calibrated digital photograph.

Secondary

Measure	Time frame	Description
Time to ulcer healing	0 to 360 days	Complete re-epithelialisation of ulcer area.
Total time of active venous ulcer	0 to 360 days	Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026