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The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention). |
|
| Early Intervention | Active Comparator | Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foam sclerotherapy | Procedure | Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous ulcer area | Venous ulcer area measured from calibrated digital photograph. | 0 to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ulcer healing | Complete re-epithelialisation of ulcer area. | 0 to 360 days |
| Total time of active venous ulcer | Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital, Vascular Department | Oulu | 90220 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601296 | Derived | 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. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
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| Endothermal ablation | Procedure | Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable. |
|
| 0 to 360 days |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |