Skip to main content
OpenTrials
Completed

NCT Number: NCT03795064

Immediate Versus Early Endovenous Ablation In Venous Ulcer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital, Vascular Department

Oulu, 90220, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foam sclerotherapy

Procedure

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

Endothermal Ablation

Procedure

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

Primary outcomes

  1. Venous ulcer area

    Time frame: 0 to 180 days

    Venous ulcer area measured from calibrated digital photograph.

Secondary outcomes

  1. Time to ulcer healing

    Time frame: 0 to 360 days

    Complete re-epithelialisation of ulcer area.

  2. Total time of active venous ulcer

    Time frame: 0 to 360 days

    Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2019
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.