Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.
SIGVARIS AG, St. Gallen, Switzerland.
Eur J Vasc Endovasc Surg. 2021 Jan;61(1):137-144. doi: 10.1016/j.ejvs.2020.09.027. Epub 2020 Oct 28.
The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking.
This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume.
All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001).
The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.
本研究旨在测试一种新型两层压力袜，其在小腿内踝上方的压力为 27-29mmHg，但足部和脚跟处无压力，与相同压缩级别（23-32mmHg）的标准压力袜相比，是否更容易穿脱，同时评估两种类型的袜子对日间水肿的预防作用。
这是一项开放标签随机对照试验，纳入了 47 名患者。所有参与者年龄均至少 65 岁，且单腿患有 C3-C6 级慢性静脉疾病。主要终点是穿着成功；次要终点是脱卸成功、一天内预防日间水肿、穿着袜子的舒适度。患者随机分配到两组之一。在每组中，两种类型的压力袜均以交叉研究的方式进行比较，以评估穿脱的容易程度。随后，患者全天穿着分配给他们的组的压力袜，以评估舒适度和对日间腿部体积的影响。
所有参与者均能独立穿上新型压力袜，而标准压力袜为 75%（p<0.001）。新型压力袜的独立脱卸成功率为 100%，而标准压力袜为 66%（p<0.001）。两组患者在穿着一天后腿部体积的减少没有显著差异。新型压力袜也被评为比标准压力袜更舒适（p<0.001）。
与相同压缩级别的标准压力袜相比，无足部和脚跟区域压缩的新型压力袜更容易穿脱，且在预防水肿方面没有劣势。
