Sub-ulcer Foam Sclerotherapy in Patients with Venous Leg Ulcer, Analysis and Technical Aspects of 134 Consecutive Patients.

OBJECTIVE: For this retrospective study, we analyzed the sub-ulcer foam sclerotherapy technique in patients with venous leg ulcer (VLU). METHODS: This study included 134 patients treated with sub-ulcer foam sclerotherapy at the Oulu University Hospital vascular outpatient clinic from January 2012 to December 2021. All included patients received sub-ulcer foam sclerotherapy as part of the treatment strategy for superficial venous insufficiency. Compression therapy and local wound care were organized for VLU treatment. A follow-up visit was scheduled for one month after the sub-ulcer foam sclerotherapy. Change in ulcer size, local (skin necrosis, infection) or systemic (deep vein thrombosis, pulmonary embolism) complications, and time to ulcer healing were monitored. The occurrence of major limb-related complications (amputation, surgical revision) was monitored for one year postoperatively. RESULTS: One month after sub-ulcer treatment, ulcers were smaller or completely healed in 108 (81%) patients. Ulcer healing was completed in 123 (92%) patients at one year and 131 (98%) patients at two years. Complications were recorded in four (3%) patients, three (2%) who were diagnosed with erysipelas requiring antibiotic treatment and one (1%) patient diagnosed with local dermatitis. During the one-year follow-up, no major limb-related complications (surgical revisions or amputations) arose. CONCLUSIONS: Sub-ulcer foam sclerotherapy may be a feasible addition to superficial vein reflux elimination in patients with VLU and a low risk for complications.

A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study.

BACKGROUND: Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease. METHODS: Consecutive patients with symptomatic varicose disease (CEAP clinical class C2-C3) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, ID NCT04774939.

Factors associated with delayed venous ulcer healing after endovenous intervention for superficial venous insufficiency.

OBJECTIVE: This retrospective trial analyzed the effect of predetermined variables on venous ulcer healing after endovenous ablation of insufficient veins. METHODS: A total of 259 patients presenting 273 venous leg ulcers (VLUs) at Oulu University Hospital vascular outpatient clinic between January 2010 and December 2020 were included in the study. In addition to compression therapy, all patients received endovenous ablation (endothermal ablation and/or foam sclerotherapy) to promote venous healing. The hazard ratio (HR) for an ulcer to heal was analyzed in univariate analysis of predetermined factors, including age, sex, recurrent venous ulcer, presence of great saphenous vein or small saphenous vein reflux, persistent superficial vein reflux after ablation, recanalization in treated segments, ulcer age, body mass index >35 kg/m2, history of deep vein thrombosis, history of erysipelas, ability to move, smoking, hypertension, atrial fibrillation, coronary artery disease, diabetes mellitus, and cardiac insufficiency. Logistic regression was used in a multivariate analysis to identify independent risk factors for ulcer healing. RESULTS: In the univariate analysis, healing was negatively associated with persistent superficial vein reflux after ablation (HR, 0.117; 95% confidence interval [CI], 0.088-0.354), recanalization in treated segments (HR, 0.161; 95% CI, 0.060-0.433), nonambulatory patient (HR, 0.322; 95% CI, 0.130-0.800), history of deep vein thrombosis (HR, 0.518; 95% CI, 0.294-0.910), and presence of small saphenous vein reflux (HR, 0.565; 95% CI, 0.384-0.830). Independent risk factors included persistent superficial vein reflux after ablation (HR, 0.123; 95% CI, 0.0051-0.295). All the patients in the persistent superficial vein reflux group had their VLUs eventually healed after further endovenous treatment. CONCLUSIONS: When treating patients with VLUs, persistent superficial vein reflux after ablation was negatively associated with ulcer healing. After additional endovenous ablative treatment, ulcers with persistent reflux eventually healed.

Recovery and patient satisfaction following radiofrequency ablation and concomitant foam sclerotherapy of varicose veins with and without compression: A randomized controlled non-inferiority trial.

BACKGROUND: The benefits of postoperative compression are not well established following radiofrequency ablation of the truncal vein and concomitant foam sclerotherapy. METHODS: A total of 104 patients were randomized: Postoperatively, 54 patients received no compression and 50 patients received class II thigh-high compression. The primary outcome for this study was the difference between means on postoperative pain scores over the first 10 days follow-up measured on a visual analog scale (VAS) from 0 to 100 mm (prespecified delta 10 mm). RESULTS: The difference between means in no compression and compression group on postoperative pain scores over the 10 days follow-up was 2.1 mm (95% confidence interval -5.1-9.3 mm; p = 0.28) indicating non-inferiority. Patients in the no compression group were more satisfied with the visual appearance of the treated leg at 1 month (p = 0.003). CONCLUSION: Over the first 10 postoperative days, no compression was non-inferior to compression on pain scores.

Ten years of experience with first-visit foam sclerotherapy to initiate venous ulcer healing.

OBJECTIVE: We evaluated the effect of first-visit foam sclerotherapy compared with scheduled treatment for patients with venous ulceration. METHODS: The study design was a retrospective comparative study. From December 2009 to October 2019, a total of 245 venous ulcers in 214 patients (including recurrent ulcers) were treated at Oulu University Hospital. Of these 245 venous ulcers, 143 were treated with first-visit foam sclerotherapy (group A) and 102 with scheduled treatment (group B). All patients received endovenous ablation (foam sclerotherapy and/or endothermal ablation) and compression therapy to promote venous ulcer healing. The primary outcome was the interval to ulcer healing, determined by Kaplan-Meier survival analysis. The secondary outcomes included the time to ulcer healing from the receipt of referral and ulcer recurrence. RESULTS: The median time to ulcer healing was 2.3 months for group A and 3.2 months for group B (P = .002). The estimated median ulcer healing times after referral for a first session of endovenous ablation were 2.7 months with a delay of <1 month from the referral, 3.3 months with a delay of 1 to 2 months, and 5.0 months with a delay of >2 months (P = .002). In group A, recurrent ulcers were recorded for 11 patients (7.7%). In group B, recurrent ulcers were recorded for 12 patients (11.8%; P = .281). CONCLUSIONS: The results of the present retrospective comparative study support first-visit foam sclerotherapy as an effective method to initiate endovenous ablation to promote venous ulcer healing. In venous ulcers, delays to endovenous ablation should be avoided whenever possible.

Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial.

OBJECTIVE: To compare post-operative compression with no compression, after radiofrequency endothermal ablation (RFA) of a truncal varicose vein and concomitant foam sclerotherapy of the tributaries. METHODS: This prospective randomised controlled, non-inferiority trial recruited patients from two centres in Northern Ostrobothnia, Finland. Patients with clinical class C2-C4 chronic venous disease were randomised to receive no compression after the operation, or to receive compression stockings continuously for two days, and then, during the daytime for five days. In follow up visits, additional foam sclerotherapy was performed for symptoms of distal incompetence. Patients were followed up for six months. The primary outcome was occlusion of the RFA treated truncal vein at six months. Secondary outcomes were return to full activity within 14 days, Aberdeen Varicose Vein Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications. RESULTS: Of 177 included patients, 90 were allocated to post-operative compression and 87 to no compression. At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042). Within 14 days of treatment, full physical activity was achieved by 87% of the compression group and 81% of the no compression group, (p = .29). At six months, the AVVQ scores were comparable and significantly improved in both groups, compared with baseline. Pain scores were comparable between groups, in day to day analyses, and they were significantly lower in both groups on day 10, compared with pre-operative pain caused by varicose veins. On average, post-operative pain medication was used for 2.3 days and for 2.8 days in the compression and no compression groups, respectively (p = .28). Complications throughout the six month follow up were comparable between groups, although skin rash/blisters occurred more often in the compression group (p = .01). CONCLUSION: After treating C2-C4 varicose veins with RFA and concomitant foam sclerotherapy, no post-operative compression was non-inferior to post-operative compression, in terms of safety and efficacy. ClinicalTrials.gov Identifier: NCT02890563.