A randomized trial of class 2 and class 3 elastic compression in the prevention of recurrence of venous ulceration

Abstract

Background: Venous leg ulcers (VLUs) are a major health problem because of their high prevalence and associated high cost of care. Despite the widespread use of compression, treatment recurrence rates remain high. Numerous studies have suggested that regular use of compression stockings reduces VLU recurrences. However, there are limited data concerning how long compression hosiery should be worn after ulcer healing and which class of compression hosiery achieves better results in the prevention of VLU recurrences.

Methods: An open, prospective, randomized, single-center study with a 5-year follow-up was performed to establish the efficacy of two different strengths of knee-high compression hosiery (class 2 and class 3) in the prevention of VLU recurrences. The study included patients with recently healed venous ulcers and no significant arterial disease, rheumatoid disease, diabetes mellitus, and restriction in range of ankle movement. Overall, 361 patients were randomized, and 308 patients (170 men, 138 women; mean age, 59 years) completed the study. Patients were randomized into two groups: group A, 186 patients who wore a heel-less open-toed elastic class 3 compression device knitted in tubular form (Tubulcus; Laboratoires Innothera, Arcueil, France); and group B, 175 patients who wore a class 2 elastic stocking (Rudo, Nis, Serbia). All patients were instructed to wear compression stockings continuously for the first 2 years of follow-up (both during the day and at night). In the third, fourth, and fifth years of follow-up, patients were instructed to wear elastic stockings during the day only. The main outcome measures were recurrence of leg ulceration and compliance with the treatment.

Results: Rates of ulcer recurrence after the 5 years of follow-up were 28.98% for the compression class 3 group and 60% for the compression class 2 group (P < .001, log-rank test). Patients in the compression class 3 group experienced significantly longer absolute (46 vs 40 months; P < .001, Mann-Whitney U test) and proportional (77% vs 67%; P < .001, Mann-Whitney U test) ulcer-free time after 5 years than those in the compression class 2 group. Rates of noncompliance after 5 years were 10.23% for the compression class 3 group and 6.25% for the compression class 2 group (P = .188, χ² test).

Conclusions: The results obtained in this study suggest that class 3 compression stockings provide a statistically significant lower recurrence rate compared with the class 2 compression stockings.

Keywords: Compliance; Compression; Recurrence; Venous ulcers.