Clinical trial NCT04737941: Finnish Venous Ulcer Study (FINNULCER Study)
Official title: Finnish Venous Ulcer Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: Venous Leg Ulcer
Foam Sclerotherapy
Endothermal Ablation
Sub-ulcer Foam Sclerotherapy
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2021-02-04
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.

In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).

Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.

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).

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

Primary outcomes:
measure: Time to ulcer Healing
timeFrame: 0-365 days
Secondary outcomes:
measure: EQ-5D Questionnaire
timeFrame: 0-365 days
measure: Wound-QOL Questionnaire
timeFrame: 0-365 days
measure: Venous ulcer area
timeFrame: 0-365 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Jyväskylä
country: Finland
facility: Keski-Suomen keskussairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Oulu University Hospital
name: Toni Pihlaja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Karoliina Halmesmaki, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Maarit Venermo, Professor
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Matti Pokela, Docent
role: STUDY_CHAIR
References:
citation: Pihlaja T, Torro P, Ohtonen P, Romsi P, Pokela M. Ten years of experience with first-visit foam sclerotherapy to initiate venous ulcer healing. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):954-960. doi: 10.1016/j.jvsv.2020.11.012. Epub 2020 Nov 25.