Health TrialsbyHealthPanel

Finnish Venous Ulcer Study (FINNULCER Study)

ConditionVenous Leg Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOulu University Hospital

About this trial

This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Leg ulcers other than venous etiology

Ulcers requiring operation theater revision

Patent foramen ovale

Several times recurrent (over 3 recurrences) venous ulcer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endothermal Ablation

    Procedure/Surgery

    Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)

  • Foam Sclerotherapy

    Procedure/Surgery

    Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: First-visit foam sclerotherapyExperimental treatment 2 interventions
Group B: Scheduled treatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to ulcer Healing

Complete re-epithelialisation of ulcer area

Time frame
0-365 days

Secondary outcomes

1

EQ-5D Questionnaire

Score 0-100 where higher is better

Time frame
0-365 days
2

Wound-QOL Questionnaire

Score 0-17 where lower is better

Time frame
0-365 days
3

Venous ulcer area

Reduction on venous ulcer maximum diameter

Time frame
0-365 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oulu University Hospital

Lead sponsor

Helsinki University Central Hospital

Collaborator

Source ClinicalTrials.gov
Apply now