Finnish Venous Ulcer Study (FINNULCER Study)

Venous Ulcer Clinical Trial

Official title:

Finnish Venous Ulcer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737941
• Other study ID #: 3/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2021
• Source: Oulu University Hospital
• Contact: Matti Pokela, Docent
• Phone: 083152011
• Email: matti.pokela[@]ppshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter randomized controlled trial compares immediate foam sclerotherapy vs. scheduled endovenous treatment in patients with venous ulceration.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Procedure:
• Endothermal Ablation
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
• Foam Sclerotherapy
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Paijat-Hame Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Satakunta Central Hospital	Pori
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Finland	Vaasa Central Hospital	Vaasa

Sponsors (2)

Lead Sponsor	Collaborator
Oulu University Hospital	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. 2020 Nov 25. pii: S2213-333X(20)30638-7. doi: 10.1016/j.jvsv.2020.11.012. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ulcer Healing	Complete re-epithelialisation of ulcer area	0-365 days
Secondary	EQ-5D Questionnaire	Score 0-100 where higher is better	0-365 days
Secondary	Wound-QOL Questionnaire	Score 0-17 where lower is better	0-365 days
Secondary	Venous ulcer area	Reduction on venous ulcer maximum diameter	0-365 days