Finnish Venous Ulcer Study (FINNULCER Study)

Study Overview
=================
Brief Summary
-----------------
This multicenter randomized controlled trial compares immediate foam sclerotherapy vs. scheduled endovenous treatment in patients with venous ulceration.

Detailed Description
-----------------
To evaluate the effect of first-visit foam sclerotherapy, patients with venous ulcer are randomly assigned to first-visit foam sclerotherapy- or to scheduled treatment group. The primary outcome for this study is time to ulcer healing. For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group. Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2). For the primary outcome the follow-up time is one year. In both groups endothermal ablation and/or foam sclerotherapy are used to treat the ulcer-related insufficient veins and truncal insufficiency. Class 2 thigh-high compression, or best possible compression therapy patient tolerates is facilitated in both groups

Official Title
-----------------
Finnish Venous Ulcer Study

Conditions
-----------------
Venous Ulcer

Intervention / Treatment
-----------------
* Procedure: Endothermal Ablation
* Procedure: Foam Sclerotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient informed consent Venous ulcer, aged from one month to one year Duplex ultrasonography verified (vein reflux greater than >0.5 second) superficial venous insufficiency Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index > 0,8 / Toe pressure >60mmhg) Exclusion Criteria: Leg ulcers other than venous etiology Ulcers requiring operation theater revision Patent foramen ovale Several times recurrent (over 3 recurrences) venous ulcer Body Mass Index over 40 Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate foam sclerotherapy<br>Immediate foam sclerotherapy group patients are treated with immediate (first-visit) foam sclerotherapy and truncal vein endothermal ablation is scheduled when anatomy is suitable. Compression therapy is started immediately. | Procedure: Endothermal Ablation<br>* Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)<br>Procedure: Foam Sclerotherapy<br>* Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.<br>|
| Active Comparator: Scheduled treatment<br>Scheduled treatment group patients are treated with scheduled endovenous ablation including foam sclerotherapy and/or endothermal ablation depending on reflux anatomy. Compression therapy is started immediately. | Procedure: Endothermal Ablation<br>* Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)<br>Procedure: Foam Sclerotherapy<br>* Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ulcer Healing | Complete re-epithelialisation of ulcer area | 0-365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D Questionnaire | Score 0-100 where higher is better | 0-365 days | 
| Wound-QOL Questionnaire | Score 0-17 where lower is better | 0-365 days | 
| Venous ulcer area | Reduction on venous ulcer maximum diameter | 0-365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous ulcer, Foam sclerotherapy, Endothermal ablation