A Randomized Trial of Moderate (Class 2), High (Class 3), and Very High (Class 4) Elastic Compression in the Prevention of Recurrence of Venous Ulceration

Venous leg ulcers (VLUs) are an important health problem because of their high prevalence and associated high cost of care. Despite many available contemporary treatment modalities (surgery, endovenous thermal ablation, foam sclerotherapy, compression), recurrence rates remain high and range between 25% and 70% according to different studies. Numerous studies have suggested that regular use of compression stockings reduces VLU recurrences. However, there are limited data concerning two important questions: How long should compression hosiery be worn after ulcer healing, and which class of compression hosiery achieves better results in the prevention of VLU recurrences? The aim of this study was to establish the efficacy of three different strengths of compression (class 2, class 3 and class 4) in the prevention of VLU recurrences. An open, prospective, randomized, single-center study with a 10-year follow-up was performed. There were 477 patients (240 men, 237 women; mean age, 59 years) with recently healed venous ulcers and no significant arterial disease, rheumatoid disease, or diabetes mellitus who were randomized into three groups: group A, 149 patients who were wearing a class 2 elastic stocking (Rudo, Nis, Serbia); group B, 167 patients who were wearing a heelless open-toed elastic class 3 compression device knitted in tubular form (Tubulcus; Laboratoires Innothera, Arcueil, France); and group C, 161 patients who were wearing a multilayer compression system composed of Tubulcus compression device and one elastic bandage 15 cm wide and 5 m long (Niva, Novi Sad, Serbia). The main outcome measures were recurrence of leg ulceration and compliance with treatment. There were 117 patients (24.52%) who did not comply with the randomized compression class: 24 (16.1%) in class 2, 34 (20.36%) in class 3, and 59 (36.65%) in class 4 (P < .05). Overall, 65% (234/360) of patients had recurrent leg ulceration by 10 years. Recurrence occurred in 120 (96%) of 125 class 2 compression cases, in 89 (66.9%) of 133 class 3 compression cases, and in 25 (24.5%) of 102 class 4 compression cases (P < .05; graph; Kaplan-Meier survival analysis showing ulcer recurrence at 10 years). The results obtained in this study suggest that compression systems with the higher compression class provide a statistically significant lower recurrence rate compared with elastic compression of lower class.