Immediate Versus Early Endovenous Ablation In Venous Ulcer
Primary Purpose
Venous Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Foam sclerotherapy
Endothermal ablation
Sponsored by
About this trial
This is an interventional treatment trial for Venous Ulcer focused on measuring Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins
Eligibility Criteria
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
Sites / Locations
- Oulu University Hospital, Vascular Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Intervention
Early Intervention
Arm Description
Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
Outcomes
Primary Outcome Measures
Venous ulcer area
Venous ulcer area measured from calibrated digital photograph.
Secondary Outcome Measures
Time to ulcer healing
Complete re-epithelialisation of ulcer area.
Total time of active venous ulcer
Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
Full Information
NCT ID
NCT03795064
First Posted
January 4, 2019
Last Updated
March 3, 2021
Sponsor
Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03795064
Brief Title
Immediate Versus Early Endovenous Ablation In Venous Ulcer
Official Title
Immediate Versus Early Endovenous Ablation In Venous Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer
Keywords
Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
Arm Title
Early Intervention
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
Intervention Type
Procedure
Intervention Name(s)
Foam sclerotherapy
Intervention Description
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
Intervention Type
Procedure
Intervention Name(s)
Endothermal ablation
Intervention Description
Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
Primary Outcome Measure Information:
Title
Venous ulcer area
Description
Venous ulcer area measured from calibrated digital photograph.
Time Frame
0 to 180 days
Secondary Outcome Measure Information:
Title
Time to ulcer healing
Description
Complete re-epithelialisation of ulcer area.
Time Frame
0 to 360 days
Title
Total time of active venous ulcer
Description
Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
Time Frame
0 to 360 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oulu University Hospital, Vascular Department
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immediate Versus Early Endovenous Ablation In Venous Ulcer
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