- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03795064
Immediate Versus Early Endovenous Ablation In Venous Ulcer
April 2, 2024 updated by: Toni Pihlaja, Oulu University Hospital
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing.
This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention).
Patients in control group will receive foam sclerotherapy at four weeks (early intervention).
Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable.
The primary outcome for this study is the reduction of venous ulcer area at four weeks.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oulu, Finland, 90220
- Oulu University Hospital, Vascular Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Leg ulcers other than venous etiology
- Pregnancy
- General contraindications for foam sclerotherapy
- Ulcers requiring operation theater revision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
|
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.
|
Active Comparator: Early Intervention
Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Venous ulcer area
Time Frame: 0 to 180 days
|
Venous ulcer area measured from calibrated digital photograph.
|
0 to 180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to ulcer healing
Time Frame: 0 to 360 days
|
Complete re-epithelialisation of ulcer area.
|
0 to 360 days
|
Total time of active venous ulcer
Time Frame: 0 to 360 days
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Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
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0 to 360 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2018
Primary Completion (Actual)
January 30, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
January 4, 2019
First Posted (Actual)
January 7, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 268/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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