Addressing the Impact of Deep Venous Stenting on the Management of Venous Ulcer.

BACKGROUND: Venous ulcers are a late and severe form of chronic venous insufficiency and account for 70% of all etiologies that cause leg ulcers in the lower limb, and they account for 20% of the 2.5 million cases complaining of chronic venous disease. Our study aims to investigate the effect of venous stenting of the deep veins on the healing of the venous ulcer. METHODS: This is a single-center, retrospective study conducted on prospectively recorded medical records of 78 patients with chronic deep venous diseases-C6 (either nonocclusive iliac venous lesion or post-thrombotic syndrome). Our lesion involved May-Thurner lesions, occlusions, insufficiencies, or stenoses owing to an affection of the venous outflow segment. All our patients underwent endovascular management, and those who did not respond successfully were transitioned to compression therapy. We then compared the outcomes of both groups in terms of ulcer healing and quality of life. RESULTS: A total of 78 patients (78 limbs), with a mean age of 39.6 ± 8.06 (range: 22-60) years, were treated. Fifty-four patients (67.9%) were males, and 24 (32.1%) were female. The etiology was primary nonocclusive iliac venous lesion in 12 limbs (16.2%) and secondary post-thrombotic obstructions in 66 (83.7%). Follow-up of the ulcer with compliance to compression therapy and standard care of the ulcer, sustained ulcer healing (reduction in ulcer area) was achieved in 60% of limbs, and most of the nonocclusive healing occurred within the first 3 months (P < 0.01). CONCLUSIONS: Our results show that deep venous stenting is associated with high wound healing rates. This rate reaches a statistically significant difference in 3 months, but this difference doesn't reach statistical significance at 6 months, with less recurrence and improved quality of life with a high cumulative patency rate, and compression therapy is the mainstay of the conservative management of venous ulceration.

Quality of Life in Patients with Venous Leg Ulcers Treated by Means of Local Hyperbaric Oxygen Therapy or Local Ozone Therapy-A Single Center Study.

Background and Objectives: Venous leg ulcers pose a significant medical problem worldwide. The complexity of the problem determines the need for further interdisciplinary activities that will improve the quality of life for treated patients. This study compared the quality of life of patients with venous leg ulcers who received local hyperbaric oxygen therapy or local ozone therapy procedures as part of comprehensive treatment. Materials and Methods: The study included 129 patients (62 men and 57 women) with venous leg ulcers. Group I underwent local hyperbaric oxygen therapy (HBOT), and Group II underwent local ozone therapy (OZONE). In both groups, the patients' quality of life was assessed before the start of the treatment cycle, as well as 10 weeks and 6 months after the completion of the treatment, by means of the EQ-5D-5L questionnaire and the Polish shortened version of the SF-36 scale. Results: After completing the respective therapeutic cycle, both groups showed statistically significant (p < 0.001) improvement in quality of life, according to the EQ-5D-5L questionnaire and the SF-36 scale. Differences were noted between the 1st examination (before treatment) and the 2nd examination (10 weeks after treatment), as well as the 3rd examination (6 months after treatment). In the EQ-5D-5L assessment of anxiety and depression, self-care, and activities of daily living 6 months after the end of treatment, better results were found in the group of patients treated with local hyperbaric oxygen therapy (p < 0.001). In this group, 6 months after the end of the treatment, a statistically significantly higher result on the EQ-VAS scale was also obtained (73.09 ± 19.8 points vs. 68.03 ± 17.37 points, p = 0.043). However, in the SF-36 assessment performed 6 months after the end of treatment, better results-a statistically significantly lower value of the quality of life index-were recorded in the group of patients treated with local ozone therapy (103.13 ± 15.76 points vs. 109.89 ± 15.42 points, p < 0.015). Conclusions: Hyperbaric oxygen therapy and local ozone therapy procedures have a beneficial effect on improving the quality of life of patients with venous leg ulcers.

Percutaneous mechanical thrombectomy to remove post-thrombotic obstructions and manage post-thrombotic syndrome-associated venous leg ulceration.

BACKGROUND: Up to one half of patients with a diagnosis of deep vein thrombosis will develop post-thrombotic syndrome (PTS). Patients with PTS can develop venous leg ulcers (VLUs) due to post-thrombotic obstructions (PTOs) that contribute to prolonged ambulatory venous hypertension. The current treatments for PTS, which include chronic thrombus, synechiae, trabeculations, and inflow lesions, do not target PTOs, and such obstructions can affect stenting success. The aim of the present study was to determine whether removal of chronic PTOs using percutaneous mechanical thrombectomy would promote VLU resolution and positive outcomes. METHODS: In this retrospective analysis, the characteristics and outcomes for patients with VLUs secondary to chronic PTO who were treated using the ClotTriever System (Inari Medical) between August 2021 and May 2022 were assessed. Technical success was considered the ability to cross a lesion and introduce the thrombectomy device. Clinical success was defined as a decrease of ≥1 in the severity category for the ulcer diameter using the revised venous clinical severity score (score 0, no VLU; score 1, mild VLU [size <2 cm]; score 2, moderate VLU [size 2-6 cm]; score 3, severe VLU [size >6 cm]) at the latest follow-up visit. RESULTS: A total of 11 patients with 15 VLUs on 14 limbs were identified. Their mean age was 59.7 ± 11.8 years, and four patients (36.4%) were women. The median VLU duration was 11.0 months (interquartile range [IQR], 6.0-17.0 months), and 2 patients had VLUs secondary to a deep vein thrombosis event >40 years previously. All treatments were performed in a single session, with technical success achieved in 100% of the 14 limbs. A median of five passes (IQR, four to six passes) with the ClotTriever catheter were performed per limb. Chronic PTOs were successfully extirpated, and intraprocedural intravascular ultrasound showed effective disruption of venous synechiae and trabeculations. Stents were placed in 10 limbs (71.4%). The time to VLU resolution or the latest follow-up was 12.8 ± 10.5 weeks, and clinical success was achieved for all 15 VLUs (100%), with the revised venous clinical severity score for the ulcer diameter improving from a median of 2 (IQR, 2-2) at baseline to a median score of 0 (IQR, 0-0) at last follow-up. The VLU area had decreased by 96.6% ± 8.7%. Of the 15 VLUs, 12 (80.0%) had resolved completely, and 3 had demonstrated near-complete healing. CONCLUSIONS: All patients showed complete or near-complete VLU healing within a few months after mechanical thrombectomy. Mechanical extirpation and interruption of chronic PTOs allowed for luminal gain and restoration of cephalad inflow. With additional investigation, mechanical thrombectomy with the study device could prove a vital component to the treatment of VLUs secondary to PTOs.

Venous Ulcer in a 5-Year-Old Girl.

BACKGROUND: Agenesis of the inferior vena cava (IVC) is an extremely rare congenital malformation. Although IVC dysplasia can present with symptoms, because of the low prevalence of this disease, it is often omitted from routine examination. Most reports on this topic have described the absence of the IVC; the absence of both a deep venous system and the IVC is even rarer. Chronic venous hypertension and varicosities leading to venous ulcers have been reported in patients with absent IVC that could be surgically bypassed; however, the absence of iliofemoral veins precluded any bypass procedure in the present patient. CASE PRESENTATION: The authors report a case of IVC below renal vein hypoplasia in a 5-year-old girl who presented bilaterally with venous stasis dermatitis and ulcers in the lower extremity limb area. Ultrasonography revealed no clear IVC and iliofemoral venous system under the renal venous plane. Magnetic resonance venography subsequently confirmed the same findings. The patient's ulcers were healed by compression therapy and routine wound care. CONCLUSIONS: This is a rare case of venous ulcer in a pediatric patient stemming from congenital IVC malformation. With this case, the authors demonstrate the etiology of the appearance of venous ulcers in children.

Effect of hyperbaric oxygen therapy on the patients with venous leg ulcer: A systematic review and meta-analysis.

This systematic review and meta-analysis aim to explore the adjuvant effect of hyperbaric oxygen therapy (HBOT) in patients with venous leg ulcer (VLU) undergoing surgeries and non-surgeries. Literatures were searched from Web of Science, Cochrane Library, Embase, Pubmed, Wan fang, China National Knowledge Infrastructure (CNKI), and VIP from inception to November 15, 2022. The risk ratio (RR) and weighted mean difference (WMD) were used as effect size for categorical variables and continuous variables, respectively, with 95% confidence interval (95%CI). The heterogeneity was assessed using Q-test and quantified as I2. Sensitivity analysis was performed for all outcomes. A total of 11 studies were finally included in this study, with a total of 617 patients (313 in the HBOT group and 304 in the control group). Results showed that HBOT in combination with surgeries was associated with shorter ulcer healing time (WMD: -13.76, 95%CI: -20.42 to -7.10), lower VAS score (WMD: -0.95, 95% CI: -1.83 to -0.07), and smaller ulcer area (WMD: -2.64, 95%CI: -3.86 to -1.42). HBOT in combination with non-surgeries was associated with higher ulcer PAR (WMD: 20.82, 95%CI: 5.86 to 35.79), but no statistical significance was found in the improvement of ulcer area (WMD: 0.79, 95% CI: -1.54 to 3.12). Our results indicating that HBOT had a good adjuvant effect in surgeries to treat VLU, and its effect in non-surgeries needed further studies.

Radiofrequency ablation of varicose veins in combination with ultrasonic-assisted wound debridement and platelet-rich plasma as well as platelet-rich fibrin technologies in treatment of lower extremity venous ulcers in office-based surgery.

Introduction: for the treatment of varicose ulcer performed clinical and laboratory reasoning of the use of ultrasonic-assisted venous ulcer debridement and Platelet-rich plasma with radiofrequency ablation in an outpatient setting, was carried out. Methods: ultrasonic-assisted debridement of trophic ulcer were performed for 50 patients with lower extremity varicose veins at decompensation stage. The effectiveness of ultrasonic-assisted debridement was evaluated by indicators of bacteriological, morphological, cytological study and assessment of trophic ulcers according to the MEASURE system. After ultrasonic-assisted debridement, the patients were divided into two groups: 30 patients, who underwent combined Platelet-rich plasma to stimulate wound regeneration and 20 patients, for whom the Granuflex hydrocolloid bandage was applied for the same purpose. Results: a comparative analysis of ulcer regeneration in two groups of patients proved that in cases of platelet rich plasma the time of transition from inflammatory-regenerative type to regenerative one is much shorter than when using a hydrocolloid dressing. In 28 patients undergoing Platelet-rich plasma (PRP) and Platelet-rich fibrin (PRF), the radiofrequency ablation of the principal superficial and perforating veins was performed. Another 22 patients performed autodermoplasty of trophic ulcers after radiofrequency ablation. Conclusion: our experience has shown that in a one-day inpatient surgical clinic such a multidisciplinary approach to treatment of venous ulcers, including ultrasonic-assisted debridement that is stimulation of wounded process by Platelet-rich plasma with further surgeries to remove the causes of decompensated chronic insufficiency, is promising regarding low costs of treatment and rehabilitation of these patients.

Risk of new onset major depressive disorder among patients with varicose veins: A multi-institution database study.

OBJECTIVE: Varicose vein is a vascular disorder that may cause negative impact on quality of life. However, little is known about the association between varicose vein and major depressive disorder. The aim of this study was to evaluate the risks of major depressive disorder among individuals with varicose veins. METHOD: The study subjects of this retrospective cohort study were selected based on Chang Gung Research Database data from January 1st, 2005, to December 31st, 2015. We used ICD-9-CM codes 454 to determine the subjects diagnosed with varicose veins. We matched patients with varicose veins to participants without varicose veins at a 1:4 ratio by gender, age, and index date. The follow-up period for new onset major depressive disorder was extended to December 31st, 2017. The hazard ratios of major depressive disorder were estimated using Cox regression analysis with competitive risk model adjusting with gender, age, and comorbidities. RESULTS: A total of 10,640 patients with varicose veins and 42,560 matched controls were enrolled. The varicose veins group had higher incidence rates of new onset major depressive disorder (adjusted hazard ratio 1.46; 95% confident interval, 1.17-1.82, p < 0.001). Compared with matched controls, varicose veins patients with or without venous ulcers had 2.26- and 1.39-times increased risk of developing new onset major depressive disorder, respectively. CONCLUSIONS: Patients with varicose veins have an increased risk in developing major depressive disorder. Clinicians should be aware of mental health in patients with varicose veins, and psychosocial support is important for these patients.

[Modern concept about trophic venous ulcers]. / Venoznye troficheskie yazvy.

Venous trophic ulcer is a common complication of chronic venous diseases that have a negative impact on the quality of life and result negative socio-economic consequences. There are three main theories of development of venous trophic ulcers. The criterion is visible trophic changes of skin (CEAP class C4). If correction of etiological factor of ulcer is impossible, local management is preferred. There are various wound coverings which can be used for the treatment of trophic ulcers. However, data on their effectiveness are sometimes unavailable. Therefore, it is necessary to systematize knowledge about modern measures and methods of exposure to trophic ulcers. The authors also discuss current understanding of pathophysiology, symptoms and diagnosis of venous trophic ulcers.

Ultrasound-guided foam sclerotherapy as a therapeutic modality in venous ulceration.

OBJECTIVES: The objective of this systematic review and meta-analysis was to evaluate rates of ulcer healing following ultrasound-guided foam sclerotherapy (UGFS). METHODS: The MEDLINE, CENTRAL and Embase databases were used to search for relevant studies using the terms ' (sclerotherapy AND ulcer) OR (vein AND ulcer) OR (sclerotherapy AND vein)'. Heterogeneity between studies was quantified using the I2 statistic. A random effects model was used to calculate risk ratios where substantial heterogeneity was found. RESULTS: The initial search yielded 8266 articles. 8 studies were included in the qualitative synthesis and 3 in the meta-analysis. Superior complete ulcer healing rates were noted in patients treated with foam sclerotherapy versus compression therapy alone (pooled OR 6.41, 95% CI = 0.3-148.2, p = 0.246, random effects method). A marked degree of heterogeneity was observed between studies (I2 = 81%). CONCLUSION: A prospective, trial is warranted in order to determine the true merits of UGFS in the setting of venous ulceration.

Periodontal (formerly type VIII) Ehlers-Danlos syndrome: Description of 13 novel cases and expansion of the clinical phenotype.

Periodontal Ehlers-Danlos syndrome (pEDS) is a rare condition caused by pathogenic variants in the C1R and C1S genes, encoding subunits C1r and C1s of the first component of the classical complement pathway. It is characterized by early-onset periodontitis with premature tooth loss, pretibial hyperpigmentation and skin fragility. Rare arterial complications have been reported, but venous insufficiency is rarely described. Here we report 13 novel patients carrying heterozygous pathogenic variants in C1R and C1S including three novel C1S variants (c.962G > C, c.961 T > G and c.961 T > A). In addition to the pEDS phenotype, three patients and one relative displayed widespread venous insufficiency leading to persistent varicose leg ulcers. One patient suffered an intracranial aneurysm with familial vascular complications including thoracic and abdominal aortic aneurysm and dissection and intracranial aneurysm rupture. This work confirms that vascular complications can occur, although they are not frequent, which leads us to propose to carry out a first complete non-invasive vascular evaluation at the time of the diagnosis in pEDS patients. However, larger case series are needed to improve our understanding of the link between complement pathway activation and connective tissue alterations observed in these patients, and to better assess the frequency, type and consequences of the vascular complications.

Correlation of venous symptoms with iliac vein stenosis on magnetic resonance imaging.

OBJECTIVE: Magnetic resonance imaging (MRI) is used in patients with lower extremity venous disease to screen for iliac vein stenosis. The objective of the present study was to determine the prevalence of iliac vein stenosis and associated lower extremity venous symptoms in consecutive patients undergoing MRI of the pelvis. METHODS: A retrospective study of all consecutive adult patients who had undergone MRI of the pelvis for various indications from March 2012 to June 2016 was performed. The electronic medical records (EMRs) were reviewed for patient characteristics and, specifically, for the presence and laterality of venous symptoms. All MRI scans were reviewed, and the maximal degree of iliac vein stenosis was recorded. All the patients also responded to a brief telephone survey inquiring about the presence of venous symptoms. Two thresholds of venous stenosis, ≥50% and ≥70%, were used to correlate its presence with the presence of venous symptoms determined from the EMR review and telephone survey results. RESULTS: A total of 120 patients were included, with a mean age of 53 ± 14 years; 79% were women and 79% were white. The prevalence of iliac vein stenosis ≥50% was significantly greater on the left than on the right (34.2% vs 16.7%; P < .001). The survey demonstrated that 44 of the 120 patients (36.7%) had had venous symptoms compared with only 30 patients (25%) according to the EMR review (P = .001). No differences were found between patients with positive vs negative survey results for venous symptoms and the occurrence of iliac vein stenosis ≥50% on the right (17.2% vs 15.2%; P = .78) or the left (38% vs 26.8%; P = .22). We also found no differences when the occurrence of iliac vein stenosis ≥70% was used as threshold between the right (2.3% vs 3%; P = .99) and the left (10.1% vs 2.4%; P = .16). Analysis of the venous symptoms from the EMR review yielded similar results. CONCLUSIONS: In our study, iliac vein stenosis was more common on the left and was encountered in up to one third of patients who had undergone MRI of the pelvis. No correlation was found in our study between the presence of iliac vein stenosis and the occurrence of ipsilateral venous symptoms. Venous symptoms were underreported in the EMRs. Further studies are necessary to identify the predictors of pathologic iliac vein stenosis.

Examining risk factors and preventive treatments for first venous leg ulceration: A cohort study.

BACKGROUND: Large studies that examine risk factors for first occurrence of venous leg ulcerations are needed to guide management. OBJECTIVE: To investigate factors associated with development of first occurrence of venous leg ulcerations. METHODS: A retrospective cohort study using a validated national commercial claims database of patients with venous insufficiency. Subjects were followed to determine whether they developed first occurrence of venous leg ulcerations, and risk and protective factors were analyzed. RESULTS: Adjusted hazard ratio (AHR) for comorbidities demonstrated an increased risk in men (AHR 1.838; 95% confidence interval [CI] 1.798-1.880), older age (45-54 years: AHR 1.316, 95% CI 1.276-1.358; 55-64 years, AHR 1.596, 95% CI 1.546-1.648), history of nonvenous leg ulceration (AHR 3.923; 95% CI 3.699-4.161), anticoagulant use (AHR 1.199; 95% CI 1.152-1.249), antihypertensive use (AHR 1.067; 95% CI 1.040-1.093), and preexisting venous insufficiency including chronic venous insufficiency (AHR 1.244; 95% CI 1.193-1.298), edema (AHR 1.224; 95% CI 1.193-1.256), and chronic venous hypertension (AHR 1.671; 95% CI 1.440-1.939). Possible protective factors were having venous surgery (AHR 0.454; 95% CI 0.442-0.467), using compression stockings (AHR 0.728; 95% CI 0.705-0.753), using prescribed statin medications (AHR 0.721; 95% CI 0.700-0.743), and using pain medications (AHR 0.779; 95% CI 0.757-0.777). LIMITATIONS: Risk of misclassification, given the use of International Classification of Diseases, Ninth Revision codes. Possible confounding factors such as body mass index could not be adequately controlled with these codes. CONCLUSION: The new evidence presented supports a paradigm shift toward venous leg ulceration prevention.

[Comprehensive treatment of indolent trophic ulcers of venous aetiology]. / Kompleksnoe lechenie dlitel'no nezazhivaiushchikh troficheskikh iazv venoznoi étiologii.

AIM: The study was undertaken to evaluate efficacy of comprehensive treatment with the use of erbium laser radiation in patients suffering from venous trophic ulcers of lower limbs. PATIENTS AND METHODS: The study included a total of seventy-six 45-to-80-year-old patients. Of these, there were 43 (56.6%) women and 33 (43.4%) men. The duration of the disease averagely amounted to 10.8±4.8 years. In 38 patients, the bottom of the ulcerative defect was with pronounced periulcerative inflammation and various degree of purulent discharge. All patients were admitted to the surgical department and underwent meticulous examination. Erbium laser irradiation was carried out with consideration for the ulcer size. Laser irradiation was performed at a wavelength of 2940 nm, pulse duration - 0.3 ms, laser beam diameter - 7 mm with radiation power of 2.19 J/cm2. RESULTS: Efficacy of treatment was assessed in dynamics by the degree of pain syndrome, ulcer size upon completion of treatment, as well as the rate of trophic ulcer epithelialisation. In 15 (19.7%) patients with varicose disease the vertical and horizontal reflux was eliminated with performing phlebectomy and echosclerotherapy. The obtained findings demonstrated that 42 (91.3%) patients of the study group had decreased terms of the beginning of purification of the fundus of the ulcer. After 6 months of rehabilitation and follow up, complete ulcer healing was achieved in 18 (64.3%) patients of the control group and in 39 (86.7%) patients of the study group. CONCLUSION: The obtained findings showed that laser radiation proved to be an effective method of treatment in patients presenting with indolent trophic ulcers. Comprehensive treatment made it possible to effectively influence the microflora and the state of regional lymph drainage, to stimulate the processes of reparative regeneration.

Assessment of the use of Unna boot in the treatment of chronic venous leg ulcers in adults: systematic review protocol.

INTRODUCTION: Chronic venous insufficiency (CVI) is an anomaly of the normal functioning of the venous system caused by valvular incompetence with or without the obstruction of venous flow. This condition can affect either or both of the superficial and the deep venous systems. Venous dysfunction can even result in congenital or acquired disorders, and its complications include venous leg ulcers (VLUs). The objective of this systematic review is to determine the effectiveness of Unna boot in the treatment of wound healing of VLU by assessing the quality of the available evidence. METHODS AND ANALYSIS: A literature search in PubMed, CINAHL, Scopus, Web of Science, Cochrane Library, BVS/BIREME, Embase, ProQuest, BDTD, Thesis and Dissertation Catalog, Sao Paulo Research Foundation/Thesis and dissertation, OPEN THESIS, A service of the US National Institute of Health, Center for Reviews and Dissemination-University of New York and SciElo published in the last 10 years, the period from January 1999 to March 2019. The review will include primary studies (original), and Controlled Trials or Observational studies (cross-sectional, case-control or longitudinal studies) with VLU. The exclusion will include leg ulceration due to different causes, such as pressure, arterial, diabetic or mixed-aetiology leg ulcers. Data synthesis will be performed using a narrative summary and quantitative analysis. ETHICS AND DISSEMINATION: This systematic review does not require approval by the ethics committee, as individual patient data will not be collected. Dissemination of findings will be through publications in peer-reviewed journals and/or via conference presentations. PROSPERO REGISTRATION NUMBER: CRD42019127947.

Prothrombotic clot properties can predict venous ulcers in patients following deep vein thrombosis: a cohort study.

Venous ulcers are the most severe manifestation of post-thrombotic syndrome (PTS). We have previously demonstrated that formation of compact fibrin clots resistant to lysis is observed in patients following deep-vein thrombosis (DVT) who developed PTS. The current study investigated whether unfavourable fibrin clot properties can predict post-thrombotic venous ulcers. In a cohort study on 186 consecutive patients following DVT, we determined plasma fibrin clot characteristics, including clot permeability and lysability, inflammatory markers, thrombin generation, fibrinolysis proteins at 3 months since the index event. Occurrence of PTS and venous ulcers was recorded during follow-up (median, 53; range 24 to 76 months). Fifty-seven DVT patients (30.6%) developed PTS, including 12 subjects (6.45%) with a venous ulcer (4 individuals with recurrent ulcers). Patients who developed ulcers compared with the remainder had at enrolment 13.0% lower clot permeability (Ks), 17.4% longer clot lysis time (CLT), 13.1% longer lag phase of clot formation, and 5.0% higher maximum absorbance, with no difference in fibrinogen, C-reactive protein, and thrombin generation. The baseline prothrombotic fibrin clot phenotype (Ks ≤ 6.5 × 10-9 cm2 and CLT > 100 min) was associated with a higher risk of ulcers [hazard ratio (HR), 5.37; 95% confidence interval (CI), 1.3-21.5]. A multivariate model adjusted for age, sex, and fibrinogen showed that independent predictors of the ulcer occurrence were body mass index (HR 1.53; 95% CI 1.30-1.86), CLT (HR 1.43; 95% CI 1.04-2.05), and α2-antiplasmin (HR 0.95; 95% CI 0.90-0.99). This study suggests that formation of denser fibrin clots with impaired fibrinolysis predisposes to post-thrombotic venous ulcers.

Protocol for a longitudinal cohort study: determination of risk factors for the development of first venous leg ulcer in people with chronic venous insufficiency, the VEINS (venous insufficiency in South Florida) cohort.

INTRODUCTION: Chronic venous insufficiency (CVI) affects up to one-third of the adult population yet venous leg ulcers (VLU), a significant complication of CVI, only affect 1%-2% of adults in the USA. Why some develop VLU and others do not is unclear. VLU have a significant impact on quality of life and are extremely costly and difficult to treat. Moreover, VLU prevalence is increasing, doubling in the last 20 years. In order to characterise the differences between people with CVI and those who ultimately develop VLU, we aim to set up the unique venous insufficiency in South Florida cohort. METHODS AND ANALYSIS: Subjects will be recruited from the University of Miami Hospital and Clinic's vascular laboratory database, which began in July 2011. Any adult age 18-95 who has had venous reflux detected on duplex ultrasound of the lower extremities is included. Approximately 2500 patients are already in the database that meet these criteria, with an estimated 2500 additional potential subjects to be recruited from the vascular laboratory database over the next 5 years. Subjects with a history of VLU prior to the duplex study date will be excluded. Data will be collected via review of the Doppler study report, patient phone interview and review of the electronic medical record. Subjects will be contacted for follow-up every 3 months for at least 5 years until the study endpoint, development of first VLU (fVLU), is reached. In order to estimate the time from reflux documentation to fVLU, Kaplan-Meier survival curves will be constructed. Cox proportional hazard regression models will be constructed to investigate possible risk factors. ETHICS AND DISSEMINATION: This study is approved by the University of Miami's Institutional Review Board. We hope to present the results of this study to the scientific community at conferences and in peer-reviewed journals.

Treatments to prevent primary venous ulceration after deep venous thrombosis.

OBJECTIVE: This systematic review and meta-analysis aimed to assess whether compression stockings or other interventions reduce the incidence of venous ulceration after acute deep venous thrombosis. METHODS: We searched PubMed and Embase for randomized controlled trials (RCTs), restricted to English, Spanish, and Hebrew, related to post-thrombotic syndrome and venous ulceration in participants with confirmed deep venous thrombosis. Our primary statistical assessment was the Peto odds ratio (OR). RESULTS: Our search generated 23 RCTs meeting inclusion and exclusion criteria, summing 6162 patients and 146 ulcerative events. Trials were categorized into compression, low-molecular-weight heparin (LMWH), procedural thrombolysis, medical thrombolysis, or miscellaneous. Six compression trials were identified, of which five were included in meta-analysis. Compression compared with placebo did not reduce venous ulceration (OR, 0.915; 95% confidence interval [CI], 0.475-1.765), and long-term compression was not superior to short-term compression (OR, 1.36; 95% CI, 0.014-1.31). Four LMWH trials were identified but were not subjected to meta-analysis because of intertrial heterogeneity. One trial, comparing extended tinzaparin with warfarin, demonstrated eight ulcers in the warfarin group and one ulcer in the LMWH group (relative risk, 0.125; P < .05). Three procedural thrombolysis trials were pooled into meta-analysis; fewer ulcerative events occurred in procedural thrombolysis patients, but the effect was not significant (OR, 0.677; 95% CI, 0.338-1.358). Eight medical thrombolysis trials were identified. Pooled analysis of five trials demonstrated a protective effect on ulceration in streptokinase patients vs standard heparinization (OR, 0.125; 95% CI, 0.021-0.739). However, these trials were of poor-quality study design, had small sample size, and had poor overall outcomes. Miscellaneous studies included a trial of hidrosmina, a vasoactive flavonoid, and a trial comparing 6-month warfarin treatment with 6 weeks; neither trial had significant outcomes. Intertrial heterogeneity was not adequately assessed with the I2 value as venous ulceration is a rare event; the Grading of Recommendations Assessment, Development, and Evaluation evidence for most trials was very low, with the exception of procedural thrombolysis trials, for which it was low. CONCLUSIONS: We found insufficient evidence to assess whether compression or other interventions protect against venous ulceration. To develop guidelines for treatment decisions related to prevention of venous ulceration, high-powered RCTs investigating venous leg ulcers as a primary outcome are required.