Venous Insufficiency: Wound Management.

PURPOSE OF REVIEW: Venous leg ulcers (VLUs) are one of the most common forms of chronic wounds and with nearly half the people having recurrent episodes, this significantly impacts a patient's quality of life. As such, VLU is a chronic disease that requires lifelong maintenance and awareness. A correct diagnosis of VLU is essential for management. RECENT FINDINGS: VLUs can be of mixed etiology and treatment should be aimed at optimizing the underlying venous hypertension based on its cause. If there is an anatomical venous reflux contributing to the non-healing of the VLU, early treatment of incompetent veins can improve healing rates. All aspects contributing to the patient's ongoing venous hypertension should be addressed to provide appropriate treatment. This can include venous interventions but also through conservative measures. Patient education and their engagement in their own care is essential for good outcomes.

Mechanochemical chemically assisted ablation of varicose veins for venous insufficiency: American vein and lymphatic society position statement.

Background: Mechanical occlusion chemically assisted ablation (MOCA) of incompetent saphenous veins has been utilized since its FDA approval in 2008. However, only recently have longer-term three and 5 year clinical follow up data become available. This updated information necessitates a societal update to guide treatment and ensure optimal patient outcomes. Method: The American Vein and Lymphatic Society convened an expert panel to write a Position Statement with explanations and recommendations for the appropriate use of MOCA for patients with venous insufficiency. Result: This Position Statement was produced by the expert panel with recommendations for appropriate use, treatment technique, outcomes review, and potential adverse events. These recommendations were reviewed, edited, and approved by the Guidelines Committee of the Society. Conclusions: MOCA is effective in alleviating symptoms and a safe treatment option for venous insufficiency. It obviates the need for tumescent anesthesia, has less procedural discomfort and lower risk of thermal nerve or skin injury. It may be used in both the below knee distal GSV as well as the SSV. However, it is associated with significantly lower rates of vessel closure and higher recanalization rates compared to both RFA and EVLA and is less cost effective than thermal techniques. It is an available option for those in whom thermal ablation is not suitable.

Generation of two iPSC lines from vascular Ehlers-Danlos Syndrome (vEDS) patients carrying a missense mutation in COL3A1 gene.

Vascular Ehlers-Danlos Syndrome (vEDS) is an inherited connective tissue disorder caused by COL3A1 gene, mutations that encodes type III collagen, a crucial component of blood vessels. vEDS can be life-threatening as these patients can have severe internal bleeding due to arterial rupture. Here, we generated induced pluripotent stem cell (iPSC) lines from two vEDS patients carrying a missense mutation in the COL3A1 (c.226A > G, p.Asn76Asp) gene. These lines exhibited typical iPSC characteristics including morphology, expression of pluripotency markers, and could differentiate to all three germ layer. These iPSC lines can serve as valuable tools for elucidating the pathophysiology underlying vEDS.

Serious Adverse Events with Cyanoacrylate Closure of Varicose Veins: An Initial Report from a Large-Scale National Survey in Japan.

Objective: Cyanoacrylate closure (CAC) is a minimally invasive technique for the treatment of varicose veins. A recent paper reported serious adverse events (AEs) associated with this use. This triggered an urgent survey to determine the incidence of AEs in Japan. Methods: The CAC-AE survey was sent to all 1,030 institutions authorized for CAC treatments. Cases performed between January 2020 and October 2023 were surveyed. Data on serious AEs and mortality were collected. Results: There were 623 surveys returned. There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (PE), and 0 cases of stroke. Deep vein occlusion due to cyanoacrylate extension was observed in 1 case. Vein resection due to infection was observed in 4 cases. There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration. Systemic allergic reactions requiring steroid administration were observed in 66 cases. There was no anaphylaxis associated with cyanoacrylate. There was one postoperative death from PE. Conclusion: This report's intent is to provide real world data on serious AEs following CAC from Japan given current concern over these events. An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.

Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative.

BACKGROUND: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment. METHODS: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom. RESULTS: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results. CONCLUSIONS: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.

Generation of induced pluripotent stem cell line from a patient suffering from arterial calcification due to deficiency of CD73 (ACDC).

Arterial calcification due to deficiency of CD73 (ACDC) is an adult onset, rare genetic vascular disorder signified by calcium deposition in lower extremity arteries and joints of hands and feet. Mutations in NT5E gene has been shown to be responsible for the inactivation of enzyme CD73 causing calcium buildup. Here, we report a iPSC line generated from a patient showing signs of ACDC and carrying a missense mutation in NT5E (c.1126A→G,p.T376A) gene. This iPSC line shows normal morphology, pluripotency, karyotype, and capability to differentiate into three germ layers, making it useful for disease modeling and investigating pathological mechanisms of ACDC.

The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine.

The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice guidelines on varicose veins. Recommendations were based on the latest scientific evidence researched following an independent systematic review and meta-analysis of five critical issues affecting the management of patients with lower extremity varicose veins, using the patients, interventions, comparators, and outcome system to answer critical questions. Part I discussed the role of duplex ultrasound scanning in the evaluation of varicose veins and treatment of superficial truncal reflux. Part II focuses on evidence supporting the prevention and management of varicose vein patients with compression, on treatment with drugs and nutritional supplements, on evaluation and treatment of varicose tributaries, on superficial venous aneurysms, and on the management of complications of varicose veins and their treatment. All guidelines were based on systematic reviews, and they were graded according to the level of evidence and the strength of recommendations, using the GRADE method. All ungraded Consensus Statements were supported by an extensive literature review and the unanimous agreement of an expert, multidisciplinary panel. Ungraded Good Practice Statements are recommendations that are supported only by indirect evidence. The topic, however, is usually noncontroversial and agreed upon by most stakeholders. The Implementation Remarks contain technical information that supports the implementation of specific recommendations. This comprehensive document includes a list of all recommendations (Parts I-II), ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with appropriate, up-to-date management of patients with lower extremity varicose veins.

A comparison of below-knee vs above-knee endovenous ablation of varicose veins.

OBJECTIVE: Varicose veins have a significant impact on quality of life and can commonly occur in the thigh and calves. However, there has been no large-scale investigation examining the relationship between anatomic distribution and outcomes after varicose vein treatment. This study sought to compare below-the-knee (BTK) and above-the-knee (ATK) varicose vein treatment outcomes. METHODS: Employing the Vascular Quality Initiative Varicose Vein Registry, 13,731 patients undergoing varicose vein ablation for either BTK or ATK lesions were identified. Outcomes were assessed using patient-reported outcomes (PROs) and the Venous Clinical Severity Score (VCSS). Continuous variables were compared using the t-test, and categorical variables were analyzed using the χ2 test. Multivariable logistic regression was used to estimate the odds of improvement after intervention. The multivariable model controlled for age, gender, race, preoperative VCSS composite score, and history of deep vein thrombosis. RESULTS: Patients who received below-knee treatment had a lower preoperative VCSS composite (7.0 ± 3.3 vs 7.7 ± 3.3; P < .001) and lower PROs composite scores (11.1 ± 6.4 vs 13.0 ± 6.6; P < .001) compared with those of patients receiving above-knee treatment. However, on follow-up, patients receiving below-knee intervention had a higher postoperative VCSS composite score (4.4 ± 3.3 vs 3.9 ± 3.5; P < .001) and PROs composite score (6.1 ± 4.4 vs 5.8 ± 4.5; P = .007), the latter approaching statistical significance. Patients receiving above-knee interventions also demonstrated more improvement in both composite VCSS (3.8 ± 4.0 vs 2.9 ± 3.7; P < .001) and PROs (7.1 ± 6.8 vs 4.8 ± 6.6; P < .001). Multivariable logistic regression analysis similarly revealed that patients receiving above-knee treatment had significantly higher odds of improvement in VCSS composite in both the unadjusted (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.28-1.65; P < .001 and adjusted (OR, 1.31; 95% CI, 1.14-1.50; P < .001) models. Patients receiving above-knee treatment also had a significantly higher odds of reporting improvement in PROs composite in both the unadjusted (OR, 1.85; 95% CI, 1.64-2.11; P < .001) and adjusted (OR, 1.65; 95% CI, 1.45-1.88; P < .001) models. CONCLUSIONS: Treatment region has a significant association with PROs and VCSS composite scores after varicose vein interventions. Preoperatively, there were significant differences in the composite scores of VCSS and PROs with patients receiving BTK treatment exhibiting less severe symptoms. Yet, the association appeared to reverse postoperatively, with those receiving BTK treatments exhibiting worse PROs, worse VCSS composites scores, and less improvement in VCSS composite scores. Therefore, BTK interventions pose a unique challenge compared with ATK interventions in ensuring commensurate clinical improvement after treatment.

A systematic review on ablation techniques for larger saphenous veins in patients with symptomatic superficial venous disease.

OBJECTIVE: The aim of this study was to summarize the existing evidence for the treatment of saphenous veins >10 mm in diameter, to determine whether there were vein size limits for treatment modalities, and to determine if there are specific technical considerations for treatment of large veins. METHODS: We searched the literature for reports of treatment methods and outcomes for patients with large-diameter saphenous veins treated with various ablation methods between 1993 and 2023. These studies were evaluated for the size of the vein determined as "large diameter," type of ablation method, study type, outcomes, adverse events, and any technical considerations noted. A systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. The COVIDENCE software was used for full-text screening and data extraction. Three reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: Seventy-one records were identified, of which 24 studies were deemed appropriate for extraction. Most of the studies identified reported outcomes of endovenous thermal ablation modalities. There were fewer studies on non-thermal, non-tumescent techniques, and these studies reported an overall lower occlusion rate compared with endovenous thermal ablation techniques. CONCLUSIONS: Large head-to-head trials or randomized controlled that compare all the modalities over a long follow-up duration are yet to be performed. In the existing literature, there is considerable heterogeneity in terms of the study size, design, definition of large veins, site of vein measurement, and follow-up periods, making it challenging to make fair comparisons and draw firm conclusions. Currently available evidence supports the use of endothermal ablation techniques for the treatment of veins >10 mm in diameter as they have a more favorable efficacy and safety profile and have a larger body of evidence available compared with non-thermal, non-tumescent techniques or surgery.

Variations and inconsistencies in venous ablation coverage policies between single-state and multistate carriers in the United States.

BACKGROUND: Vein ablation is a common and effective treatment for patients with chronic venous insufficiency. The overuse of vein ablation despite the existence of evidence-based guidelines has resulted in insurance companies developing restrictive policies for coverage that create barriers to appropriate care. This study compares the insurance coverage by single-state carriers (SSCs) and multistate carriers (MSCs), highlighting the variations and inconsistencies in the various policies. METHODS: The American Venous Forum Venous Policy Navigator was reviewed for the various policies available in the United States. The policies were divided into SSCs and MSCs. The characteristics of the policies, including the anatomic and hemodynamic criteria for specific veins, duration of conservative treatment, disease severity, symptoms, and types of procedures covered, were compared between the two groups. SAS, version 9.4 (SAS Institute Inc) was used for statistical analysis. RESULTS: A total of 122 policies were analyzed and divided between SSCs (n = 85; 69.7%) and MSCs (n = 37; 30.3%). A significant variation was found in the size requirement for great saphenous vein ablation. Although 48% of the policies did not specify a size criterion, the remaining policies indicated a minimal size, ranging from 3 to 5.5 mm. However, no significant differences were found between SSCs and MSCs. Similar findings were encountered for the small and anterior accessory saphenous veins. MSCs were more likely to define a saphenous reflux time >500 ms compared with SSCs (81.1% vs 58.8%; P = .04). A significant difference was found between the SSCs and MSCs in the criteria for perforator ablation in terms of size and reflux time. MSCs were significantly more likely to provide coverage for mechanochemical ablation than were SSCs (24.3% vs 8.2%; P = .03). SSCs were more likely to require ≥12 weeks of compression stocking therapy than were MSCs (76.5% vs 48.7%; P = .01). No significant differences were found in the clinical indications between the two groups; however, MSCs were more likely to mention major hemorrhage than were SSCs. CONCLUSIONS: The results of this study highlight the variations in policies for venous ablation, in particular, the striking inconsistencies in size criteria. MSCs were more likely to cover mechanochemical ablation and require a shorter duration of conservative therapy before intervention compared with SSCs. Evidence-based guidance is needed to develop more coherent policies for venous ablation coverage.

The potential of chatbots in chronic venous disease patient management.

Objective: Health care providers and recipients have been using artificial intelligence and its subfields, such as natural language processing and machine learning technologies, in the form of search engines to obtain medical information for some time now. Although a search engine returns a ranked list of webpages in response to a query and allows the user to obtain information from those links directly, ChatGPT has elevated the interface between humans with artificial intelligence by attempting to provide relevant information in a human-like textual conversation. This technology is being adopted rapidly and has enormous potential to impact various aspects of health care, including patient education, research, scientific writing, pre-visit/post-visit queries, documentation assistance, and more. The objective of this study is to assess whether chatbots could assist with answering patient questions and electronic health record inbox management. Methods: We devised two questionnaires: (1) administrative and non-complex medical questions (based on actual inbox questions); and (2) complex medical questions on the topic of chronic venous disease. We graded the performance of publicly available chatbots regarding their potential to assist with electronic health record inbox management. The study was graded by an internist and a vascular medicine specialist independently. Results: On administrative and non-complex medical questions, ChatGPT 4.0 performed better than ChatGPT 3.5. ChatGPT 4.0 received a grade of 1 on all the questions: 20 of 20 (100%). ChatGPT 3.5 received a grade of 1 on 14 of 20 questions (70%), grade 2 on 4 of 16 questions (20%), grade 3 on 0 questions (0%), and grade 4 on 2/20 questions (10%). On complex medical questions, ChatGPT 4.0 performed the best. ChatGPT 4.0 received a grade of 1 on 15 of 20 questions (75%), grade 2 on 2 of 20 questions (10%), grade 3 on 2 of 20 questions (10%), and grade 4 on 1 of 20 questions (5%). ChatGPT 3.5 received a grade of 1 on 9 of 20 questions (45%), grade 2 on 4 of 20 questions (20%), grade 3 on 4 of 20 questions (20%), and grade 4 on 3 of 20 questions (15%). Clinical Camel received a grade of 1 on 0 of 20 questions (0%), grade 2 on 5 of 20 questions (25%), grade 3 on 5 of 20 questions (25%), and grade 4 on 10 of 20 questions (50%). Conclusions: Based on our interactions with ChatGPT regarding the topic of chronic venous disease, it is plausible that in the future, this technology may be used to assist with electronic health record inbox management and offload medical staff. However, for this technology to receive regulatory approval to be used for that purpose, it will require extensive supervised training by subject experts, have guardrails to prevent "hallucinations" and maintain confidentiality, and prove that it can perform at a level comparable to (if not better than) humans. (JVS-Vascular Insights 2023;1:100019.).

Varicose Veins: Approach, Assessment, and Management to the Patient with Chronic Venous Disease.

Varicose veins are tortuous and dilated veins commonly seen in chronic venous disease. This article will review chronic venous disease, including its differential diagnosis, workup, and treatment.

A Nurse-Led Care Delivery App and Telehealth System for Patients Requiring Wound Care: Mixed Methods Implementation and Evaluation Study.

BACKGROUND: Innovative solutions to nursing care are needed to address nurse, health system, patient, and caregiver concerns related to nursing wellness, work flexibility and control, workforce retention and pipeline, and access to patient care. One innovative approach includes a novel health care delivery model enabling nurse-led, off-hours wound care (PocketRN) to triage emergent concerns and provide additional patient health education via telehealth. OBJECTIVE: This pilot study aimed to evaluate the implementation of PocketRN from the perspective of nurses and patients. METHODS: Patients and part-time or per-diem, wound care-certified and generalist nurses were recruited through the Stanford Medicine Advanced Wound Care Center in 2021 and 2022. Qualitative data included semistructured interviews with nurses and patients and clinical documentation review. Quantitative data included app use and brief end-of-interaction in-app satisfaction surveys. RESULTS: This pilot study suggests that an app-based nursing care delivery model is acceptable, clinically appropriate, and feasible. Low technology literacy had a modest effect on initial patient adoption; this barrier was addressed with built-in outreach and by simplifying the patient experience (eg, via phone instead of video calls). This approach was acceptable for users, despite total patient enrollment and use numbers being lower than anticipated (N=49; 17/49, 35% of patients used the app at least once beyond the orientation call). We interviewed 10 patients: 7 who had used the app were satisfied with it and reported that real-time advice after hours reduced anxiety, and 3 who had not used the app after enrollment reported having other resources for health care advice and noted their perception that this tool was meant for urgent issues, which did not occur for them. Interviewed nurses (n=10) appreciated working from home, and they reported comfort with the scope of practice and added quality of care facilitated by video capabilities; there was interest in additional wound care-specific training for nonspecialized nurses. Nurses were able to provide direct patient care over the web, including the few participating nurses who were unable to perform in-person care (n=2). CONCLUSIONS: This evaluation provides insights into the integration of technology into standard health care services, such as in-clinic wound care. Using in-system nurses with access to electronic medical records and specialized knowledge facilitated app integration and continuity of care. This care delivery model satisfied nurse desires for flexible and remote work and reduced patient anxiety, potentially reducing postoperative wound care complications. Feasibility was negatively impacted by patients' technology literacy and few language options; additional patient training, education, and language support are needed to support equitable access. Adoption was impacted by a lack of perceived need for additional care; lower-touch or higher-acuity settings with a longer wait between visits could be a better fit for this type of nurse-led care.

Cyanoacrylate glue reactions: A systematic review, cases, and proposed mechanisms.

OBJECTIVE: Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases. METHODS: We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis. CONCLUSIONS: Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.

VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers.

OBJECTIVE: Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. METHODS: The VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. RESULTS: We enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. CONCLUSIONS: Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.