Immediate Versus Early Endovenous Ablation In Venous Ulcer
1 other identifier
interventional
23
1 country
1
Brief Summary
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2018
CompletedFirst Submitted
Initial submission to the registry
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedApril 3, 2024
April 1, 2024
4.2 years
January 4, 2019
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venous ulcer area
Venous ulcer area measured from calibrated digital photograph.
0 to 180 days
Secondary Outcomes (2)
Time to ulcer healing
0 to 360 days
Total time of active venous ulcer
0 to 360 days
Study Arms (2)
Immediate Intervention
EXPERIMENTALPatients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
Early Intervention
ACTIVE COMPARATORPatients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
Interventions
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Leg ulcers other than venous etiology
- Pregnancy
- General contraindications for foam sclerotherapy
- Ulcers requiring operation theater revision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oulu University Hospital, Vascular Department
Oulu, 90220, Finland
Related Publications (1)
Pihlaja T, Ohtonen P, Romsi P, Pokela M. Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial. Phlebology. 2025 Jun;40(5):324-329. doi: 10.1177/02683555241304030. Epub 2024 Nov 27.
PMID: 39601296DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vascular Specialist
Study Record Dates
First Submitted
January 4, 2019
First Posted
January 7, 2019
Study Start
December 5, 2018
Primary Completion
January 30, 2023
Study Completion
August 30, 2023
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share