Background: In the treatment of venous leg ulcers, vasoactive drugs such as diosmin-hesperidin micronized purified flavonoids (DH) and, more recently, sulodexide (SDX), have been used besides compression therapy and local measures. The purpose of this study was to investigate whether the combined administration of both SDX and DH is better than DH alone in the treatment of venous ulcers.
Methods: In an open-label, observational, non-parallel trial, 70 patients (90 venous ulcers) were treated with multi-layer bandaging, local measures and DH, 37 patients (50 ulcers) also received SDX, 33 patients (40 ulcers) without SDX were the control group. The evolution of leg ulcers and lipodermatosclerosis was evaluated by computerized imaging measurement.
Results: The initial clinical characteristics of both groups were similar. Ulcer size showed a faster reduction in the group receiving SDX (P<0.01). With SDX, all of the ulcers were healed by week 12, in the control group, all ulcers were healed at week 21 (P<0.01 between groups). Lipodermatosclerosis improved in both groups, but it decreased faster in the SDX group. No adverse effects attributed to the medications were seen in either group.
Conclusions: The combined administration of SDX and DH was effective in accelerating ulcer healing, controlling pain and improving lipodermatosclerosis.