Randomised controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance

Abstract

The aim of this study was to determine the rate of venous ulcer recurrence and the level of compliance in patients wearing European class 1 or class 2 compression stockings. A total of 100 patients with healed venous leg ulcers were recruited, and were randomised to either class 1 (n = 50) or class 2 (n = 50) compression stockings. Follow-up was at 1 week, 3, 6, 9 and 12 months to monitor ulcer recurrence and compliance. Patients had a duplex scan to identify the source of venous incompetence. The rate of ulcer recurrence after 12 months was 16·1%, and the difference in recurrence rate between classes was not statistically significant (P = 0·287) although greater numbers in class 1 developed a recurrence. Participants (88·9%) were compliant; non-compliant patients were at a significantly greater risk of recurrence (P≤ 0·0001). Thirteen patients had both superficial and deep incompetence; those randomised to class 1 stockings (n = 4) developed ulcer recurrence. Patients with a history of multiple episodes of ulceration were more likely to develop a recurrence (P = 0·001). The lowest venous ulcer recurrence rates were seen in patients who were compliant with hosiery regardless of the compression level. Patients with both superficial and deep incompetence had a lower rate of recurrence with class 2 compression.

Keywords: Compliance; Compression hosiery; Recurrence; Venous leg ulcers.