Benefits of an Adjustable Compression Garment System for the Reduction of Chronic Leg Oedema (ACROE Study)

Abstract

This study aimed to assess whether a specific adjustable compression garment (ACG) system (Coolflex Standard Calf and Coolflex Standard Foot; Sigvaris Inc.) promotes self care in patients with chronic leg oedema. Secondary aims were to assess the effectiveness of this ACG in reducing oedema, improving patient reported outcomes, and determining the patients' degree of satisfaction with the handling of the wrap. This was a multicentre prospective observational study. The study included 99 adult patients aged between 18 and 90 years presenting with chronic oedema of the lower extremity, which encompasses conditions such as lymphoedema, venous oedema, and phlebolymphoedema. At baseline, all patients received an ACG. After two to three days and after six weeks, their overall satisfaction with the therapy was assessed. Leg volume was determined in a contactless manner during the baseline and follow up visits. All patients completed the cross-cultural adaptation of the Lymphoedema Functioning, Disability and Health Questionnaire for Patients with Lymphoedema of the Lower Extremity in Germany (Lymph-ICF-UG). A total of 86 patients completed the study and were followed up for six weeks. At the final six week follow up , 82 (95.3%) of the 86 subjects indicated that they were able to put on the wrap independently or with a little help from relatives. The overall satisfaction rate was 88.5% (95% confidence interval [CI], 80.4 - 94.1%). The mean leg volume reduction from baseline to six weeks was -4.7% (95% CI -6.3 - -3.0%; p < .001). Lymph-ICF-UG scores and scores in all domains improved significantly from baseline to the final follow up. The ACG used in this study was found to promote self care in a high proportion of patients with chronic leg oedema. A significant reduction in oedema was observed.