BACKGROUND: The aim of this study was to investigate the effect of a purified, micronised, flavonoid fraction (Daflon) in lower limb oedema developed after delayed embolectomy and successful reperfusion of acutely ischaemic legs. METHODS: Our series consisted of 19 patients with prolonged, acute ischaemia of the lower extremity caused by arterial embolism, who had undergone successful embolectomy. Patients were randomised into two groups; ten patients (group I) treated with flavonoids, were compared to nine given a placebo. Ankle and calf circumferences, venous capacitance and venous emptying time were measured preoperatively [T1], on the 2nd [T2], 5th [T3], 8th [T4] and 30th [T5] postoperative days. RESULTS: An increase of ankle and calf circumference up to 9% and 13.5% respectively, as compared with preoperative values was demonstrated. There was a reduction in oedema formation in patients with the Daflon group, which reached statistical significance only in the ankles (p=0.0276). Calf differences were statistically significant on the second and fifth postoperative days (p<0.05). Venous haemodynamics were considerably improved by Daflon (p<0.001). CONCLUSIONS: Daflon 500 mg had an inhibitory effect on moderate oedema developed after revascularisation of an ischaemic limb.
RCT Entities:
BACKGROUND: The aim of this study was to investigate the effect of a purified, micronised, flavonoid fraction (Daflon) in lower limb oedema developed after delayed embolectomy and successful reperfusion of acutely ischaemic legs. METHODS: Our series consisted of 19 patients with prolonged, acute ischaemia of the lower extremity caused by arterial embolism, who had undergone successful embolectomy. Patients were randomised into two groups; ten patients (group I) treated with flavonoids, were compared to nine given a placebo. Ankle and calf circumferences, venous capacitance and venous emptying time were measured preoperatively [T1], on the 2nd [T2], 5th [T3], 8th [T4] and 30th [T5] postoperative days. RESULTS: An increase of ankle and calf circumference up to 9% and 13.5% respectively, as compared with preoperative values was demonstrated. There was a reduction in oedema formation in patients with the Daflon group, which reached statistical significance only in the ankles (p=0.0276). Calf differences were statistically significant on the second and fifth postoperative days (p<0.05). Venous haemodynamics were considerably improved by Daflon (p<0.001). CONCLUSIONS:Daflon 500 mg had an inhibitory effect on moderate oedema developed after revascularisation of an ischaemic limb.