Clinical research study
From the American Venous Forum
Prevention of recurrence of venous ulceration: Randomized controlled trial of class 2 and class 3 elastic compression

Presented at the Tripartite Meeting of the Venous Forum of the Royal Society of Medicine, American Venous Forum, and the European Venous Forum, London, UK, June 29th, 2006.
https://doi.org/10.1016/j.jvs.2006.05.051Get rights and content
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Objective

To compare venous ulcer recurrence and compliance with two strengths of compression hosiery.

Methods

This study was a randomized controlled trial with a 5-year follow-up. The setting was the leg ulcer clinics of a teaching and a district general hospital in Scotland, United Kingdom. Patients were 300 outpatients with recently healed venous ulcers, with no significant arterial disease, rheumatoid disease, or diabetes mellitus. Interventions were fitting and supply of class 2 or class 3 compression hosiery. Four-monthly refitting by trained orthotists and surveillance by specialist nurses were performed. The main outcome measures were recurrence of leg ulceration and compliance with treatment.

Results

Thirty-six percent (107/300) of patients had recurrent leg ulceration by 5 years. Recurrence occurred in 59 (39%) of 151 class 2 elastic compression cases and in 48 (32%) of class 3 compression cases. One hundred six patients did not comply with their randomized compression class, 63 (42%) in class 3 and 43 (28%) in class 2. The difference in recurrence is not statistically significant, but our estimate of the effectiveness of class 3 hosiery is diluted by the lower compliance rate in this group. Restricted ankle movement and four or more previous ulcers were associated with a higher risk of recurrence.

Conclusions

There was no evidence of a difference in recurrence rates at the classic level of significance (5%), but the lowest recurrence rates were seen in people who wore the highest degree of compression. Therefore, patients should wear the highest level of compression that is comfortable.

Cited by (0)

Supported by the Chief Scientist Office, Scotland. We received compression hosiery from Medi UK. The data analysis and manuscript preparation were undertaken independently of any sponsors. The opinions expressed in this article are those of the authors and not of the funders.

Competition of interest: none.