Immediate Versus Early Endovenous Ablation In Venous Ulcer

Venous Ulcer Clinical Trial

Official title:

Immediate Versus Early Endovenous Ablation In Venous Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795064
• Other study ID #: 268/2018
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2024
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Procedure:
• Foam sclerotherapy
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
• Endothermal ablation
Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Locations

Country	Name	City	State
Finland	Oulu University Hospital, Vascular Department	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous ulcer area	Venous ulcer area measured from calibrated digital photograph.	0 to 180 days
Secondary	Time to ulcer healing	Complete re-epithelialisation of ulcer area.	0 to 360 days
Secondary	Total time of active venous ulcer	Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.	0 to 360 days