Abstract:Objective The addition of ultrasound-guided peri-ulcer foam sclerotherapy (PUFS) for the incompetent network of veins in the vicinity of the ulcer has been shown to reduce the time to ulcer healing. Long term follow-up was undertaken to test the hypothesis that PUFS reduces venous leg ulcer (VLU) recurrence. Methods All patients included in the previously published RCT were followed up for a minimum period of 12 months following VLU healing, to assess VLU recurrence, quality of life (r-VCSS, SF12), and duplex findings. Results Six out of 65 patients were lost to follow-up (one death). All the remaining 58 patients were followed up for a minimum of 12 months (mean follow-up 2.2 years). Ulcer recurrence was significantly reduced in Group A, who received PUFS, compared to Group B: 3/25 (12%) vs 15/33 (45%) (p=0.006). Multivariable Cox proportional hazards regression model showed that Group A had a significantly lower hazard of recurrence compared to Group B (adjusted HR=0.20, 95% CI: 0.06–0.75, p=0.016). The mean ulcer-free time for Group A was significantly greater than Group B: 1059 (95% CI: 960-1158) days compared to 736 (95% CI: 587-885) days (p=0.002). The rVCSS was significantly lower in Group A than in Group B: 4.45 vs 7.94 (p=0.018) at final follow-up. Patients who had duplex-confirmed sub-ulcer vein obliteration at follow-up had a significantly improved ulcer-free time (log-rank test, χ2 = 9.045, p = 0.003). Conclusions The use of adjuvant PUFS reduced the recurrence rates of VLU during a mean follow-up of 2.2 years, increased ulcer-free time, and improved the quality of life. Duplex-confirmed obliteration of the refluxing sub-ulcer network of veins on follow-up was associated with a reduced VLU recurrence.
Bishara et al. (Fri,) studied this question.
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