An off-label randomised controlled trial (RCT) has found that an investigational stocking, which has no compression in the foot or heel area, is significantly easier to put on and take off, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class. This type of garment may represent a “relatively simple solution” to improving patients’ treatment adherence, write Caroline S Buset (University Hospital of Zurich, Zurich, Switzerland) and colleagues in the European Journal of Vascular and Endovascular Surgery (EJVES).
Buset and colleagues detail that the aim of the study was to test whether an investigational two-layer stocking exerting 27–29mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on (don) and take off (doff) than a standard stocking of the same compression class (23–32mmHg), and also to assess the prevention of diurnal oedema with both types of stocking.
The investigators included 47 patients in this trial, and detail that all participants were at least 65 years of age and suffered from chronic venous disease class C3–C6 in one leg. The primary endpoint was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking.
The authors state that patients were randomly allocated to one of two groups, and that 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.
Writing in EJVES, Buset et al report that all participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p<0.001). Unaided removal success was 100% with the investigational stocking versus 66% for the standard stocking (p<0.001). In addition, there was no significant difference in leg volume reduction between the study groups after a day of wear, and the investigational stocking was also rated as being more comfortable than the standard stocking (p<0.001).
Buset and colleagues recognise certain limitations of the present study. For example, they acknowledge that bias due to the open-label design of the this RCT “cannot be excluded” and that it was impossible to blind patients or clinical investigators to the investigational device as it consists of two overlapping garments, whereas the standard stocking is a single layer.
The authors summarise that the investigational stocking was significantly easier to don and doff, while displaying no inferior oedema prevention properties, compared with a standard stocking of the same compression class. “The next step will be to prove the physical properties, particularly diurnal foot volume changes and clinical effectiveness, in further RCTs,” they conclude.