Conservative versus surgical treatment of venous leg ulcers: 10-year follow up of a randomized, multicenter trial

Abstract

INTRODUCTION: Leg ulcers have a large socio-economic impact. Treatment modalities are either conservative or surgical. Conservative treatment involves local treatment and compression therapy. Surgical treatment of venous ulcers is based on correcting venous hypertension, by treating incompetent superficial, deep, and perforating veins. A prospective randomized multicenter trial comparing surgical treatment (combined superficial and perforating vein surgery) with ambulatory compression therapy was conducted during 1998 and 2001. This paper presents the results of a 10-year follow-up period of this trial. MATERIALS AND METHODS: All patients enrolled in the original prospective trial were approached and invited for additional examination and duplex ultrasound evaluation. Secondary, disease specific and generic quality-of-life (QoL) was assessed. Current ulcer state and recurrence during the follow-up period was assessed. RESULTS: After a mean of 97 months follow up, 80 (41%) out of 196 legs could be inspected. The incidence of "ulcer-free", the main outcome, was significantly (p = 0.007) higher in the surgical group (58.9%), compared to the conservative group (39.6%). Observed ulcer recurrence was 48.9% for the surgical group and 94.3% for the conservative group. The number of incompetent perforating veins appears to be a significant (p < 0.001) risk factor for not being ulcer-free. Disease specific QoL showed no significant difference between the surgical and conservative groups. CONCLUSIONS: The addition of surgical treatment in patients with venous ulceration leads to a significantly higher chance of being ulcer-free, than just ambulatory compression therapy. This effect persists after 10 years of follow up. The number of incompetent perforating veins has a significant effect on the ulcer-state and recurrence.