Department of Vascular Surgery, Gloucestershire Royal Hospital, Great Western Road, Gloucester, UK.
Eur J Vasc Endovasc Surg. 2010 Apr;39(4):495-9. doi: 10.1016/j.ejvs.2009.11.025. Epub 2009 Dec 16.
To assess whether routine use of foam sclerotherapy, in addition to four-layer compression bandaging, could speed up the healing of venous ulcers.
Randomised controlled trial involving patients recruited from a nurse-led leg ulcer clinic. A total of 315 new patients were assessed, and eleven patients were identified from follow-up clinics.
Inclusion criteria were: patients with an active venous leg ulcer, in the presence of superficial truncal venous incompetence and without total deep venous incompetence on duplex imaging. Patients were randomised to four-layer compression bandages alone (control) or with additional foam sclerotherapy to incompetent superficial truncal veins. The primary endpoint was ulcer healing 24 weeks after randomisation.
It was only possible to recruit 40 patients who were suitable for analysis: 22 control, 18 additional foam sclerotherapy. There was no complication from the foam treatment and at six months the target vein was occluded in 9 of 11 evaluable patients that had foam. One patient died before 24 weeks from an unrelated cause. At 24 weeks, 17 of 20 (85% - 1 died) in the control group and 12 of 13 (92%) patients with additional foam sclerotherapy had ulcer healing (P=0.72, log rank testing).
This trial failed to recruit sufficient patients for formal comparison, but foam sclerotherapy was feasible as an adjunct to compression therapy for venous ulceration.
Eudra CT 2005-001551-38.
评估在四层压迫绷带包扎的基础上常规使用泡沫硬化疗法是否能加速静脉溃疡的愈合。
涉及从护士主导的下肢溃疡诊所招募的患者的随机对照试验。共有 315 名新患者接受了评估，从随访诊所中确定了 11 名患者。
纳入标准为：存在活动性静脉性下肢溃疡，伴浅静脉主干功能不全，但双功能超声检查未发现深静脉完全功能不全的患者。患者被随机分为仅接受四层压迫绷带包扎（对照组）或在有功能不全的浅静脉主干上额外接受泡沫硬化疗法。主要终点是随机分组后 24 周溃疡愈合情况。
仅招募到 40 名适合分析的患者：22 名对照组，18 名额外接受泡沫硬化疗法。泡沫治疗没有并发症，在 6 个月时，11 名可评估患者中有 9 名目标静脉闭塞。1 名患者在 24 周前因与研究无关的原因死亡。在 24 周时，对照组 20 名患者中的 17 名（85% - 1 名死亡）和接受额外泡沫硬化疗法的 13 名患者中的 12 名（92%）溃疡愈合（P=0.72，对数秩检验）。
这项试验未能招募到足够的患者进行正式比较，但泡沫硬化疗法作为静脉溃疡压迫治疗的辅助手段是可行的。
Eudra CT 2005-001551-38。
