Toni Pihlaja, Pasi Ohtonen, Pekka Romsi, Matti Pokela
{"title":"静脉溃疡患者的溃疡下泡沫硬化疗法:随机对照试验。","authors":"Toni Pihlaja, Pasi Ohtonen, Pekka Romsi, Matti Pokela","doi":"10.1177/02683555241304030","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU).</p><p><strong>Design: </strong>Randomized controlled trial.</p><p><strong>Methods: </strong>This trial recruited patients with VLUs to receive either sub-ulcer foam sclerotherapy and compression therapy (study group) or compression therapy only (control group). The primary outcome of this study was the change in the venous ulcer area at 4 weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded.</p><p><strong>Results: </strong>Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8 cm<sup>2</sup> in both groups. At 4 weeks, the average reductions in ulcer areas were 4.0 cm<sup>2</sup> (SD 3.1) in the study group (95% CI 2.0 to 5.9, <i>p</i> = .001) and 2.0 cm<sup>2</sup> (SD 3.1) in the control group (95% CI: -0.1 to 4.1, <i>p</i> = .051). No differences in complications were recorded.</p><p><strong>Conclusions: </strong>At 1-month sub-ulcer foam sclerotherapy and compression therapy reduced the ulcer area statistically significantly, whereas compression therapy alone did not. Sub-ulcer foam sclerotherapy could be a good addition to superficial venous insufficiency treatment in patients with VLU.ClinicalTrials.gov identifier NCT03795064.</p>","PeriodicalId":94350,"journal":{"name":"Phlebology","volume":" ","pages":"2683555241304030"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial.\",\"authors\":\"Toni Pihlaja, Pasi Ohtonen, Pekka Romsi, Matti Pokela\",\"doi\":\"10.1177/02683555241304030\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU).</p><p><strong>Design: </strong>Randomized controlled trial.</p><p><strong>Methods: </strong>This trial recruited patients with VLUs to receive either sub-ulcer foam sclerotherapy and compression therapy (study group) or compression therapy only (control group). The primary outcome of this study was the change in the venous ulcer area at 4 weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded.</p><p><strong>Results: </strong>Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8 cm<sup>2</sup> in both groups. At 4 weeks, the average reductions in ulcer areas were 4.0 cm<sup>2</sup> (SD 3.1) in the study group (95% CI 2.0 to 5.9, <i>p</i> = .001) and 2.0 cm<sup>2</sup> (SD 3.1) in the control group (95% CI: -0.1 to 4.1, <i>p</i> = .051). No differences in complications were recorded.</p><p><strong>Conclusions: </strong>At 1-month sub-ulcer foam sclerotherapy and compression therapy reduced the ulcer area statistically significantly, whereas compression therapy alone did not. Sub-ulcer foam sclerotherapy could be a good addition to superficial venous insufficiency treatment in patients with VLU.ClinicalTrials.gov identifier NCT03795064.</p>\",\"PeriodicalId\":94350,\"journal\":{\"name\":\"Phlebology\",\"volume\":\" \",\"pages\":\"2683555241304030\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-11-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phlebology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/02683555241304030\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phlebology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/02683555241304030","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial.
Purpose: This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU).
Design: Randomized controlled trial.
Methods: This trial recruited patients with VLUs to receive either sub-ulcer foam sclerotherapy and compression therapy (study group) or compression therapy only (control group). The primary outcome of this study was the change in the venous ulcer area at 4 weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded.
Results: Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8 cm2 in both groups. At 4 weeks, the average reductions in ulcer areas were 4.0 cm2 (SD 3.1) in the study group (95% CI 2.0 to 5.9, p = .001) and 2.0 cm2 (SD 3.1) in the control group (95% CI: -0.1 to 4.1, p = .051). No differences in complications were recorded.
Conclusions: At 1-month sub-ulcer foam sclerotherapy and compression therapy reduced the ulcer area statistically significantly, whereas compression therapy alone did not. Sub-ulcer foam sclerotherapy could be a good addition to superficial venous insufficiency treatment in patients with VLU.ClinicalTrials.gov identifier NCT03795064.