Efficacy of ultrasound-guided foam sclerotherapy in the healing of venous leg ulcers.

Abstract

Background: Ultrasound-guided foam sclerotherapy (UGFS) for treating the refluxing venous network beneath and in the vicinity of venous leg ulcers (VLUs) has been used widely.

Objective: This trial aimed to assess the efficacy and safety of UGFS for treating VLUs (ISRCTN18090073).

Methods: This study is a multicenter randomized controlled trial. Consenting eligible participants were randomized into two groups: group A received UGFS for the distal refluxing network of veins (eg, ulcer bed venous plexus), in addition to standard care, and group B received standard care alone. Standard care included compression therapy, wound care, ablation of superficial reflux, and recanalization of proximal deep venous obstruction when appropriate. Patients were followed weekly until complete ulcer healing was achieved. All participants will be followed for ≥12 months from the point of randomization to allow calculation of total ulcer-free days during the study period and assess for the recurrence of ulceration from the time of ulcer healing and quality of life measures. The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing, Venous Clinical Severity Score, and patient-reported health-related quality of life.

Results: The study was terminated early for efficacy at the planned interim analysis when one-half the number of patients had completed follow-up. A total of 71 patients, 6 with bilateral VLUs, were recruited. After accounting for dropouts and losses to follow-up, 65 VLUs were available for analysis. Both groups were similar at baseline regarding demographic factors, risk factors, history of deep vein thrombosis, previous venous interventions, and ulcer size. The time to complete ulcer healing was significantly shorter in group A, who received UGFS, as compared with group B, who did not receive UGFS (median, 35 days [interquartile range, 22 days] vs median, 56 days [interquartile range, 58 days]; P = .008). Additionally, more ulcers achieved complete healing within 3 months in group A compared with group B (28/29 [97%] vs 27/36 [75%]; P = .01). Multivariate regression analysis showed a significant effect of UGFS on healing time (P = .004). Group A showed a significantly more rapid reduction in ulcer size (P < .0001). There was a significant improvement in the Venous Clinical Severity Score after treatment in both groups A and B (P < .0001).

Conclusions: Although both groups benefited from standard care for treating VLUs, the addition of UGFS improved treatment outcomes significantly. UGFS accelerated the healing process, resulting in a shorter time to complete ulcer healing and a higher rate of ulcers achieving complete healing within 3 months. These findings suggest that UGFS is a valuable adjunctive treatment for VLUs, enhancing the efficacy of standard care protocols.