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Objective: National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported. Methods: The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis. Results: After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms. Conclusions: A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.

Objectives Exercise improves haemodynamic parameters in patients with chronic venous disease. There is a paucity of evidence on its effect in post-thrombotic syndrome (PTS). The aim of this systematic review is to assess the impact of exercise in PTS. Methods Adhering to PRISMA guidelines and following PROSPERO registration (CRD42021220924), MEDLINE, Cochrane Library, EMBASE database, and trial registries were searched on 19th May 2022. Results One article met the inclusion criteria and a narrative synthesis was carried out. The included randomised controlled trial reported a between-group mean difference of 4.6 points ( p = .027) in the VEINES-QOL score and −2.0 points ( p = .14) in the Villalta score, in favour of exercise therapy. The statistical significance threshold was not reached. Conclusion Data on exercise in PTS remains sparse but exercise appears to be a safe intervention. In the context of this literature, a potential future trial and outcome reporting measures are suggested.

Objective: The primary objective of this systematic review and meta-analysis was to elucidate the rate of venous thromboembolism (VTE) following endovenous varicose vein intervention with mechanical thromboprophylaxis and additional pharmacological thromboprophylaxis, versus mechanical thromboprophylaxis alone. Summary Background Data: The VTE rate following endovenous procedures is higher than other day-case procedures and could be reduced with pharmacological thromboprophylaxis. Methods: The review followed PRISMA guidelines with a registered protocol (PROSPERO: CRD42021274963). Studies of endovenous intervention for superficial venous incompetence reporting the predefined outcomes with at least 30 patients were eligible. Data were pooled with a fixed effects model. Results: There were 221 trials included in the review (47 randomised trial arms, 105 prospective cohort studies and 69 retrospective studies). In randomised trial arms, the rate of deep venous thrombosis with additional pharmacological thromboprophylaxis was 0.52% (95% CI 0.23-1.19%) (9 studies; 1095 patients; 2 events), versus 2.26% (95% CI 1.81-2.82%) (38 studies; 6951 patients; 69 events) with mechanical thromboprophylaxis alone. The rate of pulmonary embolism in randomised trial arms with additional pharmacological thromboprophylaxis was 0.45% (95% CI 0.09-2.35) (5 studies, 460 participants, 1 event) versus 0.23% (95% CI 0.1-0.52%) (28 studies, 4834 participants, 3 events) for mechanical measures alone. The rate of EHIT grade III-IV was 0.35% (95% CI 0.09-1.40) versus 0.88% (95% CI 0.28-2.70%). There was one VTE-related mortality and one instance of major bleeding, with low rates of minor bleeding. Conclusions: There is a significant reduction in the rate of DVT with additional pharmacological thromboprophylaxis and routine prescription of anticoagulation following endovenous varicose vein intervention should be considered. VTE risk for individual study participants is heterogeneous and risk stratification in future randomised interventional studies is critical to establish the clinical effectiveness and safety of additional pharmacological thromboprophylaxis.

Groin incision surgical site infections (SSIs) following arterial surgery are common and are a source of considerable morbidity. This review evaluates interventions and adjuncts delivered immediately before, during, or after skin closure, to prevent SSIs in patients undergoing arterial interventions involving a groin incision.MEDLINE, EMBASE, and CENTRAL databases were searched.This review was undertaken according to established international reporting guidelines and was registered prospectively with the International prospective register of systematic reviews (CRD42020185170). The MEDLINE, EMBASE, and CENTRAL databases were searched using pre-defined search terms without date restriction. Randomised controlled trials (RCTs) and observational studies recruiting patients with non-infected groin incisions for arterial exposure were included; SSI rates and other outcomes were captured. Interventions reported in two or more studies were subjected to meta-analysis.The search identified 1 532 articles. Seventeen RCTs and seven observational studies, reporting on 3 747 patients undergoing 4 130 groin incisions were included. A total of seven interventions and nine outcomes were reported upon. Prophylactic closed incision negative pressure wound therapy (ciNPWT) reduced groin SSIs compared with standard dressings (odds ratio [OR] 0.34, 95% CI 0.23 - 0.51; p.001, GRADE strength of evidence: moderate). Local antibiotics did not reduce groin SSIs (OR 0.60 95% CI 0.30 - 1.21 p = .15, GRADE strength: low). Subcuticular sutures (vs. transdermal sutures or clips) reduced groin SSI rates (OR 0.33, 95% CI 0.17 - 0.65, p = .001, GRADE strength: low). Wound drains, platelet rich plasma, fibrin glue, and silver alginate dressings did not show any significant effect on SSI rates.There is evidence that ciNPWT and subcuticular sutures reduce groin SSI in patients undergoing arterial vascular interventions involving a groin incision. Local antibiotics did not reduce groin wound SSI, although the strength of this evidence is lower. No other interventions demonstrated a significant effect.

Objectives Peripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications. Methods This systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence. Results After screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p Conclusion To date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

Introduction: Post-thrombotic syndrome (PTS) is a common lifelong condition affecting up to 50% of those suffering from deep vein thrombosis (DVT). PTS compromises function and quality of life with subsequent venous ulceration in up to 29% of those affected. Areas covered: A literature review of surgical and non-surgical approaches in the prevention and treatment of PTS was undertaken. Notable areas include the use of percutaneous endovenous interventions and the use of graduated compression stockings (GCS) after acute proximal DVT. Expert opinion: In patients with acute iliofemoral DVT, we think it is important to have a frank conversation with the patient about catheter-directed thrombolysis, aiming to reduce the severity of PTS experienced. We advocate ultrasound-accelerated thrombolysis with adjunctive procedures, such as deep venous stenting for proximal iliofemoral DVT. For patients with isolated femoral DVT, we believe that anticoagulation and GCS should be recommended. In patients with established PTS, we recommend GCS for symptomatic relief. We recommend that patients engage in regular exercise where possible with the prospect of gaining symptomatic relief. For those with severe PTS that has a significant effect on quality of life, we discuss the patient’s case at a multi-disciplinary team meeting to plan for endovenous intervention.

Objectives This survey study evaluates current management strategies for venous ulceration and the impacts of the EVRA trial results. Methods An online survey was disseminated to approximately 15000 clinicians, through 12 vascular societies in 2018. Survey themes included: referral times, treatment times and strategies, knowledge of the EVRA trial and service barriers to managing venous ulceration. Data analysis was performed using Microsoft Excel and SPSS. Results 664 responses were received from 78 countries. Respondents were predominantly European (55%) and North American (23%) vascular surgeons (74%). Responses varied between different countries. The median vascular clinic referral time was 6 weeks and time to be seen in clinic was 2 weeks. This was significantly higher in the UK (p ≤ 0.02). 77% of respondents performed surgical/endovenous interventions prior to ulcer healing, the median time to intervention was 4 weeks. 31% of participants changed their practice following EVRA. Frequently encountered barriers to implementing change were a lack of operating space/time (18%). Conclusion Venous ulcers are not managed as quickly as they should be. An evaluation of local resource requirements should be performed to improve service provision for venous ulceration. When interpreting the results of this survey consideration should be given to the response rate.

Background Various guidelines exist worldwide for the diagnosis and management of venous leg ulcers; however, these are difficult to implement resulting in disparate treatment of patients globally. Method An online, 26-question survey was designed to evaluate the current global management of venous leg ulceration and was emailed globally to approximately 15,000 participants (November 2017–February 2018). Results Overall, 799 responses were received from 86 countries, with a 5% response rate. The respondent physicians saw a median of 10 (interquartile range 5–20) patients per month, with a median time to referral from primary to secondary care of six weeks. Of the respondents, 61% arranged an ankle brachial pressure index on first visit and 84% performed a venous duplex, with 95% prescribing compression for those in whom it was not contraindicated. Fifty-nine percent performed endovenous intervention or surgery prior to ulcer healing. Conclusions The survey showed a diversity of treatment pathways. The need to develop a robust, clear pathway for patients with leg ulceration is clearly required.

Background Non-thermal non-tumescent methods for varicose vein treatment have rapidly gained popularity in recent years due to clinical efficacy comparable to other endovenous methods, but with a superior safety and tolerability profile. Cyanoacrylate is an adhesive that rapidly polymerises during endovenous treatment to cause rapid occlusion of veins and initiate vein fibrosis. Method Cyanoacrylate glue treatment is known to cause complications such as phlebitis, cellulitis and deep vein thrombosis in rare instances. We present the first reported case of cyanoacrylate extravasation with chronic foreign body reaction in a patient nine months after initial treatment. Results We discuss the aetiology of this complication, its treatment, patient outcome and its significance to both clinicians and patients. Conclusion Cyanoacrylate glue embolisation can, in rare instances, lead to extravasation and chronic foreign body reaction, necessitating surgical intervention. The relative novelty of cyanoacrylate glue embolisation in the treatment of varicose veins requires clinicians to monitor for rare complications during its use in clinical practice. Patients should be aware of the rare risk of glue extravasation and foreign body reaction for fully informed consent prior to treatment.

ObjectivesAbdominal aortic aneurysm (AAA) clinical practice guidelines (CPGs) provide evidence-based information on patient management; however, methodological differences exist in the development of CPGs. This study examines the methodological quality of AAA CPGs using a validated assessment tool.MethodsMedline, EMBASE and online CPG databases were searched from 1946 to 31 October 2021. Full-text, English language, evidence-based AAA CPGs were included. Consensus-based CPGs, summaries of CPGs or CPGs which were only available on purchase were excluded. Five reviewers assessed their quality using the Appraisal of Guidelines for Research and Evaluation II instrument. An overall guideline assessment scaled score of ≥80% was considered as the threshold to recommend CPG use in clinical practice.ResultsSeven CPGs were identified. Scores showed good inter-reviewer reliability (intraclass correlation coefficient 0.943, 95% CI 0.915 to 0.964). On average, CPGs performed adequately with mean scaled scores of over 50% in all domains. However, between CPGs, significant methodological heterogeneity was observed in all domains. Four CPGs scored ≥80% (European Society of Cardiology, the Society of Vascular Surgery, the European Society of Vascular Surgery and the National Institute of Health and Care Excellence), supporting their use in clinical practice.ConclusionsFour CPGs were considered of adequate methodological quality to recommend their use in clinical practice; nonetheless, these still showed areas for improvement, potentially through performing economic analysis and trial application of recommendations. A structured approach employing validated CPG creation tools should be used to improve rigour of AAA CPGs. Future work should also evaluate recommendation accuracy using validated appraisal tools.

Introduction Evidence regarding ultrasound assessment of left common iliac vein diameter (LCIV) is limited. Extensive work is currently being undertaken worldwide on non-thrombotic iliac vein lesions to identify patients who may benefit from intervention to alleviate symptoms of chronic venous obstruction. Interventions include long-term stent implantation to improve vein diameter stenosis. This study aimed to assess a cohort of symptomatic venous patients and the diameter of the LCIV in these patients. Methods : Retrospective medical records review of all patients attending a tertiary vascular surgery centre who underwent a venous duplex ultrasound assessment between April 2017 and February 2018 were analysed for assessment of LCIV. Medical records of those patients with documented LCIV diameter were assessed over 18 months of follow-up. Results : A total of 672 (271 males, 401 females) LCIV diameter measurements were collected. The age of the patients ranged from 21 to 95 years (mean = 56.38). Median LCIV diameter overall was 7.64 mm (IQR 5.80mm–9.00 mm). 40 patients (6%) were reported to have a LCIV diameter measurement of < 4 mm, 8 (20%) male and 32 female (80%). 17 of these 40 patients (47.5%) were treated conservatively. Median LCIV diameter was 3.4 mm (IQR 2.5–3.7). 21 of these 40 patients (52.5%) underwent superficial venous intervention only, with a median LCIV diameter of 3.5 mm (IQR 3.2–3.7) and 2 out of these 40 patients (5%) underwent deep venous stenting (2/2 female – 100%), with a median LCIV diameter of 2.9 (IQR 2.9–2.9). No patients underwent both superficial and deep venous treatment in this 40 patient cohort. In those undergoing superficial venous intervention, 4 (19%) underwent repeat treatment. The two deep venous stenting patients underwent magnetic resonance venogram and venogram with intravascular ultrasound to allow stent placement, which confirmed a narrowed left common iliac vein. Primary stent patency at 18 months was 100%. Conclusion In this large study cohort of venous duplex assessments the median vein diameter was 7.64 mm and 40 patients out of 672 had a vein diameter smaller than 4 mm. 2 patients underwent deep venous stenting with primary patency of 100%.

Background Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA). Several MLLA outcome-prediction tools have been developed. These could be valuable in clinical practice, but most require validation in independent cohorts before routine clinical use can be recommended. The primary aim of this study is to evaluate the accuracy of healthcare professionals’ predictions of outcomes in adult patients undergoing MLLA for complications of chronic limb-threatening ischaemia (CLTI) or diabetes. Secondary aims include the validation of existing outcome-prediction tools. Method This study is an international, multicentre prospective observational study including adult patients undergoing a primary MLLA for CLTI or diabetes. Healthcare professionals’ accuracy in predicting outcomes at 30-days (death, morbidity and MLLA revision) and 1-year (death, MLLA revision and ambulation) will be evaluated. Sixteen existing outcome-prediction tools specific to MLLA will be examined for validity. Data collection began on 1 October 2020; the end of follow-up will be 1 May 2022. The C-statistic, Hosmer–Lemeshow test, reclassification tables and Brier score will be used to evaluate the predictive performance of healthcare professionals and prediction tools, respectively. Study registration and dissemination This study will be registered locally at each centre in accordance with local policies before commencing data collection, overseen by local clinician leads. Results will be disseminated to all centres, and any subsequent presentation(s) and/or publication(s) will follow a collaborative co-authorship model., PERCEIVE (PrEdiction of Risk and Communication of outcome following major lower limb amputation—a collaboratiVE study) is an international, multicentre prospective observational study including adult patients undergoing a primary major lower-limb amputation (MLLA) for chronic limb-threatening ischaemia (CLTI) or diabetes. It aims to evaluate the accuracy of healthcare professionals’ predictions of outcomes in adult patients undergoing MLLA for complications of CLTI or diabetes. Secondary aims include the validation of existing outcome-prediction tools in this patient cohort.

Background Updatable estimates of COVID-19 onset, progression, and trajectories underpin pandemic mitigation efforts. To identify and characterise disease trajectories, we aimed to define and validate ten COVID-19 phenotypes from nationwide linked electronic health records (EHR) using an extensible framework. Methods In this cohort study, we used eight linked National Health Service (NHS) datasets for people in England alive on Jan 23, 2020. Data on COVID-19 testing, vaccination, primary and secondary care records, and death registrations were collected until Nov 30, 2021. We defined ten COVID-19 phenotypes reflecting clinically relevant stages of disease severity and encompassing five categories: positive SARS-CoV-2 test, primary care diagnosis, hospital admission, ventilation modality (four phenotypes), and death (three phenotypes). We constructed patient trajectories illustrating transition frequency and duration between phenotypes. Analyses were stratified by pandemic waves and vaccination status. Findings Among 57 032 174 individuals included in the cohort, 13 990 423 COVID-19 events were identified in 7 244 925 individuals, equating to an infection rate of 12·7% during the study period. Of 7 244 925 individuals, 460 737 (6·4%) were admitted to hospital and 158 020 (2·2%) died. Of 460 737 individuals who were admitted to hospital, 48 847 (10·6%) were admitted to the intensive care unit (ICU), 69 090 (15·0%) received non-invasive ventilation, and 25 928 (5·6%) received invasive ventilation. Among 384 135 patients who were admitted to hospital but did not require ventilation, mortality was higher in wave 1 (23 485 [30·4%] of 77 202 patients) than wave 2 (44 220 [23·1%] of 191 528 patients), but remained unchanged for patients admitted to the ICU. Mortality was highest among patients who received ventilatory support outside of the ICU in wave 1 (2569 [50·7%] of 5063 patients). 15 486 (9·8%) of 158 020 COVID-19-related deaths occurred within 28 days of the first COVID-19 event without a COVID-19 diagnoses on the death certificate. 10 884 (6·9%) of 158 020 deaths were identified exclusively from mortality data with no previous COVID-19 phenotype recorded. We observed longer patient trajectories in wave 2 than wave 1. Interpretation Our analyses illustrate the wide spectrum of disease trajectories as shown by differences in incidence, survival, and clinical pathways. We have provided a modular analytical framework that can be used to monitor the impact of the pandemic and generate evidence of clinical and policy relevance using multiple EHR sources. Funding British Heart Foundation Data Science Centre, led by Health Data Research UK.

Background: Living in deprived areas is associated with poorer outcomes after certain vascular procedures and surgical site infection in other specialties. Our primary objective was to determine whether living in more income-deprived areas was associated with groin wound surgical site infection after arterial intervention. Secondary objectives were to determine whether living in more income-deprived areas was associated with mortality and clinical consequences of surgical site infection. Methods: Postal code data for patients from the United Kingdom who were included in the Groin Wound Infection after Vascular Exposure (GIVE) multicenter cohort study was used to determine income deprivation, based on index of multiple deprivation (IMD) data. Patients were divided into three IMD groups for descriptive analysis. Income deprivation score was integrated into the final multivariable model for predicting surgical site infection. Results: Only patients from England had sufficient postal code data, analysis included 772 groin incisions (624 patients from 22 centers). Surgical site infection occurred in 9.7% incisions (10.3% of patients). Surgical site infection was equivalent between income deprivation tertiles (tertile 1 = 9.5%; tertile 2 = 10.3%; tertile 3 = 8.6%; p = 0.828) as were the clinical consequences of surgical site infection and mortality. Income deprivation was not associated with surgical site infection in multivariable regression analysis (odds ratio [OR], 0.574; 95% confidence interval [CI], 0.038-8.747; p = 0.689). Median age at time of procedure was lower for patients living in more income-deprived areas (tertile 1 = 68 years; tertile 2 = 72 years; tertile 3 = 74 years; p

Objective Pelvic venous reflux (PVR) can present with symptoms such as chronic pelvic pain, dysmenorrhea, and dyspareunia, resulting in a decreased quality of life among those affected. Percutaneous coil embolization (CE) is a common intervention for PVR; however, the efficacy and safety of its use in isolation has yet to be reviewed. Methods The MEDLINE and EMBASE databases were systematically searched from 1990 to July 20, 2020, for studies reporting on adult patients undergoing isolated CE for PVR. Articles not in English, case reports, studies reporting on pediatric patients, and studies not performing isolated CE were excluded. Search, review, and data extraction were performed by two independent reviewers (S.S. and M.T.). Changes in pain before and after CE was evaluated through a pooled analysis of visual analogue scale scores in seven studies. Results A total of 970 patients (range, 3-218, 100% female) undergoing isolated ovarian vein or mixed veins embolization from 20 studies were included. Pooled analysis revealed mean improvements of 5.47 points (95% CI, 4.77-6.16) on the visual analogue scale. Common symptoms such as urinary urgency and dyspareunia reported significant improvements of 78-100% and 60-89.5% respectively. Complications were rare, with coil migration (n = 19) being the most common. Recurrence rates differed based on the varying symptoms and studies, with recurrence in pain 1-2 years after CE ranging from 5.9-25%. Two randomized controlled trials revealed improved clinical outcomes with CE as compared with vascular plugs and hysterectomy. Conclusions The current data suggests that isolated CE is technically effective and can result in clinical improvement among patients with PVR. However, further trials are required to ascertain its long-term effects.

Introduction A number of factors have reportedly been associated with venous leg ulceration (VLU) however many of these remain disputed. UK Biobank (UKB) is an electronic dataset that provides in-depth detail on the lives of its participants. The aim of this research is to utilise UKB to understand factors associated with VLU. Methods Participants in the UKB with historical or active venous ulceration were identified and an age, sex and comorbidity matched control group was formed. A multivariate logistic regression was used to explore factors associated with VLU with significant factors expressed through odds ratios (OR). Mortality was investigated using a Kaplan Meier plot and log-rank test. Data analysis was preformed using R Studio Version 1.2.5033 and Python 3.8.10. Results Factors associated with VLU included; male gender, older age, deprivation (OR 1.27), obesity (OR 1.40), current smoking (OR 1.21), immoderate alcohol intake (OR 1.32), previous deep vein thrombosis (OR 3.07), depression and loneliness (OR 1.21). Biochemical factors associated with VLU included low haemoglobin concentrations (OR 1.50), low circulating lymphocyte percentages (OR 1.57), raised glycated haemoglobin (HbA1c) (OR 2.92), raised c-reactive protein (OR 1.41), raised cystatin C (OR 1.11) and low Vitamin D levels (OR 1.52). At a median follow up of 11.5 years, the mortality in VLU participants was 28%; significantly higher than in controls (P Conclusion Participants with VLU are comorbid with poorer physical, social and psychological wellbeing.

Background/Objective Sport-related vascular trauma is an important consequence of increased physical activity. Repetitive, high-intensity movements predispose athletes to vascular disease, including arterial pathology, by exerting increased pressure on neurovascular structures. This is an important source of morbidity in an otherwise young and healthy population. Arterial pathology associated with repetitive trauma is often misdiagnosed as musculoskeletal injury. This article increases awareness of sport-related arterial disease by reviewing the symptomatology, investigation, and treatment modalities of this pathology. In addition, prognostic outcomes specific to the athlete are discussed. Results Arterial thoracic outlet syndrome and vascular quadrilateral space syndrome are associated with athletes involved in overhead throwing exercises. Sport-related arterial pathology of the lower limb include external iliac artery endofibrosis (EIAE), popliteal artery entrapment syndrome (PAES), and adductor canal syndrome. Vascular stress and kinking secondary to vessel tethering are important contributors to pathology in EIAE. Chronic exertional compartment syndrome must also be considered, presenting with clinical features similar to PAES. In addition, athletes are predisposed to blunt mechanical trauma. Hypothenar hammer syndrome is one such example, contributing to a high burden of morbidity in this population. Conclusions In arterial thoracic outlet syndrome and vascular quadrilateral space syndrome, surgery is advocated in symptomatic individuals, with postoperative outcomes favorable for the athlete. Acute limb ischemia may occur as a result of secondary thrombosis or embolization, often without preceding claudication. PAES and adductor canal syndrome are associated with functional entrapment in the athlete, secondary to muscular hypertrophy. Surgical exploration may be indicated. Poorer outcomes are noted when this process is associated with vascular reconstruction. Surgical treatment of EIAE follows failure of conservative management, with limited data available on postoperative prognosis. Investigations for all these conditions should be targeted based on clinical suspicion. A delay in diagnosis can have severe consequences on return to competition in these high-functioning individuals.

Objective/background The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health related quality of life (HRQoL) Methods A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. The MEDLINE and Embase databases were searched from 1946 to 31 August 2018. Reference lists of included studies were searched for further relevant papers. Full text studies in English reporting the relationship between great and small saphenous vein diameters and clinical severity and/or HRQoL scores measured using validated instruments were included. All study designs were included. Studies that did not include relationships between these parameters, non-English studies, and studies focusing on non-truncal veins were excluded. Two reviewers independently performed the study selection, data extraction, and risk of bias assessment. Results Eleven eligible studies were identified, reporting on 2,732 limbs (range 22–681). Four studies correlated truncal vein diameter with both clinical severity and HRQoL, while seven reported only on clinical severity measures. Multiple instruments were used to quantify HRQoL and clinical severity. Seven studies assessed the relationship with CEAP class, with the majority observing a positive correlation between vein diameter and disease severity. Four studies found weak correlations with VCSS, with one showing correlations with VCSS components. No significant relationship between diameters and HRQoL scores was reported. One study also revealed no correlation with Aberdeen Varicose Vein Questionnaire improvements post-treatment. The majority of studies failed to include C0 and C1 participants. Conclusions While further studies are required to improve the level of evidence, the existing literature suggests that truncal vein diameters correlate with clinical severity. Diameters are a poor predictor of HRQoL, with no relationship to patients’ perceived impact of chronic venous disease. As such, vein diameter should not be used as a measure to decide who needs venous intervention.

Chronic venous disease (CVD) represents a significant healthcare burden. Thrombophilia is proposed as a risk factor, particularly for post‐thrombotic CVD. A systematic review was performed to determine the relationship between thrombophilia and non‐thrombotic CVD. MEDLINE® and Embase® databases were searched from 1946 up to March 2018. Case‐control studies, cohort studies or randomised clinical trials reporting on thrombophilias in non‐thrombotic lower limb CVD in adult patients were included. Non‐English and post‐thrombotic syndrome studies were excluded. Study selection and data extraction were performed by two reviewers. Fifteen studies were included, reporting on 916 cases and 1261 controls. Studies largely focused on venous ulceration and investigated multiple haemostatic factors. An association between thrombophilia and non‐thrombotic CVD was identified, with greater prevalence and factor concentration alteration reported in patients compared to controls. Concomitant thrombophilia presence was associated with earlier CVD onset. Relationship strength varied, with commoner aetiologies showing clearer correlation than rarer ones. Thrombophilia is associated with non‐thrombotic CVD but the mechanism is unclear and causation cannot be determined. Future research should focus on prospective studies with larger populations and identify adjunct therapies targeting thrombophilia.

Objective: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration. Summary Background Data: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies. Methods: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy. Results: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy. Conclusions: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies.

Introduction The increasing prevalence of diabetes mellitus and advances in endovascular therapies continue to have an impact on the epidemiology and management of lower extremity arterial disease. This study describes trends in lower extremity revascularisation and major lower limb amputation in NHS England over the past two decades (2000–2019). Methods Numbers of lower extremity endovascular interventions, open surgical procedures and major lower limb amputations performed in NHS England between 2000 and 2019 were extracted from publicly available hospital admitted patient care activity reports. Trends in intervention were assessed with linear regression models and chi-square tests for trend. Results Over this period, 527,131 revascularisations and 92,053 amputations were performed. The mean age of patients was 67.5 years (standard deviation 1.6 years) and 65.3% were male. The number of lower limb revascularisation procedures increased by 402.4 units/year (95% confidence interval, CI, 290.1–514.6, p 2 = 0.42, p = 0.003). Conclusions There has been a significant increase in the rate of lower limb revascularisation procedures associated with decreased numbers of major lower limb amputations over the past two decades. These changes in overall trends may affect both service provision and vascular surgery training planning.

This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT., The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study., Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences., J P Moulton Charitable Foundation

Introduction The incidence of flap failure in lower extremity reconstruction is significantly higher in the lower extremity compared head, neck and breast reconstruction. The commonest cause of flap failure is venous thrombosis. The aim of this study was to assess the reliability of VTE risk assessment tools in patients with open lower extremity fractures and to assess the ability of such tools to identify patients at risk of developing microvascular venous thrombosis following lower extremity free flap reconstruction. Method A single centre retrospective cohort study was conducted between August 2012-August 2019. All patients were risk assessed using the Department of Health (DoH), Modified Caprini and Padua VTE risk assessment tools. Result 58 patients were included, all were at high risk of DVT according to the DoH (mean score± SD, 3.7±0.93), Caprini (10.2±1.64) and Padua (5.4±0.86) risk assessment tools. All patients received thromboprophylaxis, the incidence of clinical deep venous thrombosis was 0%. Intraclass correlation coefficient demonstrated moderate agreement between the Caprini and DoH (0.73, 95% CI 0.54-0.84, p Conclusion Current VTE risk assessment tools do not identify patients at risk of developing venous complications following lower extremity reconstruction. Further prospective studies are required to optimise risk prediction models and thromboprophylaxis use in this cohort. Take-home message Current VTE risk assessment tools do not identify patients at risk of developing microvascular venous thrombosis following lower limb reconstruction.

Objective: The aim of the COVER Study is to identify global outcomes and decision making for vascular procedures during the pandemic. Background data: During its initial peak, there were many reports of delays to vital surgery and the release of several guidelines advising later thresholds for vascular surgical intervention for key conditions. Methods: An international multi-centre observational study of outcomes following open and endovascular interventions. Results: In an analysis of 1,103 vascular intervention (57 centres in 19 countries), 71.6% were elective or scheduled procedures. Mean age was 67 ± 14 years (75.6% male). Suspected or confirmed COVID-19 infection was documented in 4.0%. Overall, in-hospital mortality was 11.0%. (aortic interventions mortality 15.2% [23/151], amputations 12.1% [28/232], carotid interventions 10.7% [11/103], lower limb revascularisations 9.8% [51/521]). Chronic obstructive pulmonary disease (Odds ratio [OR] 2.02, 95% CI 1.30-3.15) and active lower respiratory tract infection due to any cause (OR 24.94, 95% CI 12.57-241.70) ware associated with mortality, whereas elective or scheduled cases were lower risk (OR 0.4, 95% CI 0.22-0.73 and 0.60, 95% CI 0.45-0.98 respectively. After adjustment, antiplatelet (Odds Ratio [OR] 0.503, 95% Confidence Interval [CI]:0.273 - 0.928) and oral anticoagulation (OR 0.411, 95% CI: 0.205 - 0.824) were linked to reduced risk of in-hospital mortality. Conclusions: Mortality following vascular interventions during this period was unexpectedly high. Suspected or confirmed COVID-19 cases were uncommon. Therefore an alternative cause e.g. recommendations for delayed surgery, should be considered. The vascular community must anticipate longer term implications for survival. Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Carotid artery stenosis causes significant morbidity and mortality accounting for approximately 8% of all ischaemic strokes. Carotid artery stenting (CAS) offers an endovascular alternative to carotid endarterectomy (CEA), suggested as a viable option in those deemed high-risk for open CEA due to comorbidities or operative technical considerations. A number of large randomised-controlled trials (RCTs) and meta-analysis comparing CAS vs. CEA in unselected patient populations support the conclusion that CAS is associated with a higher risk of stroke and CEA is associated with a higher risk of myocardial infraction. Initial promise for CAS in high-risk patients was demonstrated by The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial that reported CAS was non-inferior to CEA. However, there is evidence to suggest age-related adverse outcome in patients undergoing CAS. There is limited evidence to suggest that CEA could be suitable even in patients deemed high-risk for medical or technical reasons. Further contemporary research on the use of CAS and CEA in high-risk patients is required to re-evaluate current guidelines and high-risk criterion. It is common for a composite outcome of death, ipsilateral stroke and MI which should be questioned as subsequent quality of life is likely to differ after suffering a stroke in comparison to MI. This literature review will discuss the current evidence for CAS and CEA interventions in unselected populations and high-risk patients with carotid disease requiring intervention.

Funder: Actergy Health, BACKGROUND: This randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD). METHODS: Seventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed. RESULTS: Seventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p

Background: Surgical site infections (SSIs) of groin wounds are a common and potentially preventable cause of morbidity, mortality and healthcare costs in vascular surgery. Our aim was to define the contemporaneous rate of groin SSIs, determine clinical sequelae, and identify risk factors for SSI. Method: An international multicentre prospective observational cohort study of consecutive patients undergoing groin incision for femoral vessel access in vascular surgery was undertaken over 3 months, follow up was 90 days. The primary outcome was incidence of groin wound SSI. Results: 1337 groin incisions (1039 patients) from 37 centres were included. 115 groin incisions (8.6%) developed SSI, of which 62 (4.6%) were superficial. Patients who developed an SSI had a significantly longer length of hospital stay (6 vs 5 days, p=0.005), a significantly higher rate of post-operative acute kidney injury (19.6% vs 11.7%, p=0.018), with no significant difference in 90-day mortality. Female sex, Body Mass Index≥30kg/m2, ischaemic heart disease, aqueous betadine skin preparation, bypass/patch use (vein, xenograft or prosthetic) and increased operative time were independent predictors of SSI. Conclusion: Groin infections which are clinically apparent to the treating vascular unit are frequent and their development carries significant clinical sequelae. Risk factors include modifiable and non-modifiable variables.

Objective Determine standards of referral and management of patients with venous leg ulceration in primary care after the release of the EVRA (A Randomized Trial of Early Endovenous Ablation in Venous Ulceration) study results. Methods An online questionnaire was disseminated over four months to professionals working within primary care. Results The survey received 643 responses. Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results. Of those who answered the following questions, 410 (69.1%) stated that referral to a vascular specialist must be made by the General Practitioner and 13 (2.2%) reported that they would always refer patients for secondary care assessment before the publication of EVRA. Considering the EVRA results, 128 (29%) reported that they would change practice regarding referral and would experience no barriers and 198 (45%) reported that they would like to refer earlier but is not their decision. Barriers to changing practice included local referral policies, training and time restrictions, 266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer. Conclusion There is a considerable variation in local referral pathways for venous leg ulceration, and despite clinicians wanting to refer promptly, many primary care professionals are unable to. Unfortunately, the EVRA study alone may not change the overall practice, and work is needed to overcome barriers faced by primary care professionals.

Objectives Venous thromboembolism is a potentially fatal complication of superficial endovenous treatment. Proper risk assessment and thromboprophylaxis could mitigate this hazard; however, there are currently no evidence-based or consensus guidelines. This study surveyed UK and Republic of Ireland vascular consultants to determine areas of consensus. Methods A 32-item survey was sent to vascular consultants via the Vascular and Endovascular Research Network (phase 1). These results generated 10 consensus statements which were redistributed (phase 2). ‘Good’ and ‘very good’ consensus were defined as endorsement/rejection of statements by >67% and >85% of respondents, respectively. Results Forty-two consultants completed phase 1. This generated seven statements regarding risk factors mandating peri-procedural pharmacoprophylaxis and three statements regarding specific pharmacoprophylaxis regimes. Forty-seven consultants completed phase 2. Regarding venous thromboembolism risk factors mandating pharmacoprophylaxis, ‘good’ and ‘very good’ consensus was achieved for 5/7 and 2/7 statements, respectively. Regarding specific regimens, ‘very good’ consensus was achieved for 3/3 statements. Conclusions The main findings from this study were that there was ‘good’ or ‘very good’ consensus that patients with any of the seven surveyed risk factors should be given pharmacoprophylaxis with low-molecular-weight heparin. High-risk patients should receive one to two weeks of pharmacoprophylaxis rather than a single dose.

BackgroundThe novel Coronavirus Disease 2019 (COVID-19) pandemic is having a profound impact on global healthcare. Shortages in staff, operating theatre space and intensive care beds has led to a significant reduction in the provision of surgical care. Even vascular surgery, often insulated from resource scarcity due to its status as an urgent specialty, has limited capacity due to the pandemic. Furthermore, many vascular surgical patients are elderly with multiple comorbidities putting them at increased risk of COVID-19 and its complications. There is an urgent need to investigate the impact on patients presenting to vascular surgeons during the COVID-19 pandemic.Methods and AnalysisThe COvid-19 Vascular sERvice (COVER) study has been designed to investigate the worldwide impact of the COVID-19 pandemic on vascular surgery, at both service provision and individual patient level. COVER is running as a collaborative study through the Vascular and Endovascular Research Network (VERN) with the support of numerous national (Vascular Society of Great Britain and Ireland, British Society of Endovascular Therapy, British Society of Interventional Radiology, Rouleaux Club) and an evolving number of international organisations (Vascupedia, SingVasc, Audible Bleeding (USA), Australian and New Zealand Vascular Trials Network (ANZVTN)). The study has 3 ‘Tiers’: Tier 1 is a survey of vascular surgeons to capture longitudinal changes to the provision of vascular services within their hospital; Tier 2 captures data on vascular and endovascular procedures performed during the pandemic; and Tier 3 will capture any deviations to patient management strategies from prepandemic best practice. Data submission and collection will be electronic using online survey tools (Tier 1: SurveyMonkey® for service provision data) and encrypted data capture forms (Tiers 2 and 3: REDCap® for patient level data). Tier 1 data will undergo real-time serial analysis to determine longitudinal changes in practice, with country-specific analyses also performed. The analysis of Tier 2 and Tier 3 data will occur on completion of the study as per the prespecified statistical analysis plan.Ethical ApprovalEthical approval from the UK Health Research Authority has been obtained for Tiers 2 and 3 (20/NW/0196 Liverpool Central). Participating centres in the UK will be required to seek local research and development approval. Non-UK centres will need to obtain a research ethics committee or institutional review board approvals in accordance with national and/or local requirements.ISRCTN: 80453162 (https://doi.org/10.1186/ISRCTN80453162)Ethical Approval: 20/NW/0196 Liverpool Central, IRAS: 282224

Background Compression after sclerotherapy is commonly used, although the evidence base for this practice is unclear. This study aims to summarize and assess the evidence for compression therapy after sclerotherapy to inform clinical practice. Methods A systematic review was performed according to PRISMA guidelines via Medline and EMBASE databases (1946 to December 31, 2019) by two reviewers. Full-text, English-language studies comparing compression type and/or duration in adult chronic venous disease patients undergoing liquid or foam sclerotherapy were included. Results Nine studies were identified: five using liquid sclerotherapy, three foam sclerotherapy and one using both. Studies had short follow-up periods (6-24 weeks) and reported on clinical outcomes, quality of life, side effects and complications. In C1 patients undergoing liquid sclerotherapy, any duration of stocking use significantly decreased telangiectasia and reticular vein number and size compared with no compression. No significant difference in clinical symptoms or quality of life was seen when comparing compression duration after liquid or foam sclerotherapy in tributary or truncal veins in C2 to C6 patients. Greater superficial vein resolution was seen with stockings compared with bandages in C2 patients undergoing liquid sclerotherapy to tributary veins. A comparison of stockings vs bandaging revealed differing thrombophlebitis rates but no significant difference in pigmentation. In C2 to C6 patients undergoing foam sclerotherapy, use of 35 mm Hg stockings significantly improved post-treatment symptoms compared with 23 mm Hg stockings. This review was limited by heterogeneity of outcome measurements and the variety of comparisons between compression types and durations. Conclusions Postsclerotherapy compression may have beneficial clinical outcomes at short-term follow-up; however, evidence is lacking regarding its type, class, length, and duration. Further trials are required to guide the optimal management of postsclerotherapy patients.

Objective Our aim was to assess the methodologic quality of clinical practice guidelines (CPGs), which inform the diagnosis and management of chronic venous disease (CVD), using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Methods A systematic review was performed through the Medline and Embase databases to identify CPGs relevant to CVD. The included articles were evidence-based CPGs available in English and reported in the past 20 years. Consensus documents, expert opinions, and studies providing guidance for diagnosis or treatment alone were excluded. Four independent reviewers assessed the CPGs using the AGREE II tool across six domains. Overall quality scaled scores were calculated for each guideline, and the interrater reliability was measured using an intraclass correlation coefficient. SPSS, version 25 (IBM Corp, Armonk, NY) was used for statistical analysis. Results Six CPGs reported from 2004 to 2018 were identified; all were of European and North American origin. The interrater reliability when scoring each CPG was high, with an intraclass correlation coefficient of >0.8 (P ≤ .002) for all six CPGs. One CPG had an average score of 95.83% across all domains, qualifying as a high quality CPG. The remaining five CPGs had scores ranging from 29% to 71%. The CPGs generally performed poorly in outlining stakeholder involvement and evaluating the applicability of the guideline to clinical practice. Conclusions Scores from the AGREE II tool were reproducible when different users evaluated the CPGs. We identified one CPG for CVD of high methodologic quality. The AGREE II appraisal tool can be used to identify aspects of CPGs that can be developed to improve their methodologic quality.

Objective Acute deep venous thrombosis (DVT) can be complicated by post-thrombotic syndrome, which is associated with significant morbidity and healthcare costs. The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) was the largest and most controversial randomized controlled trial evaluating the use of pharmacomechanical catheter-directed thrombolysis (CDT) for the prevention of post-thrombotic syndrome after acute DVT. This study aimed to evaluate clinicians' opinion on the ATTRACT trial and its impact on clinical practice. Methods An online survey consisting of 10 core multiple choice items and a maximum of five follow-up open-ended questions was delivered to vascular surgeons, interventional radiologists, hematologists, and interventional cardiologists affiliated with 10 international societies between April 23 and July 1, 2019. Clinicians' views on the main limitations of the ATTRACT trial, its impact on patient selection for thrombolysis and the need for a new trial were evaluated. Results Out of 15,650 contacted clinicians, 451 (3%) completed the survey, with 74% vascular surgeons, 24% interventional radiologists, 2% hematologists, and 0.2% interventional cardiologists. The majority of respondents (79%) were aware of the results of the ATTRACT trial before completing the survey and routinely performed pharmacomechanical CDT (PCDT) in their centers (70%). Only 20% of clinicians considered ATTRACT to be a well-designed and well-performed trial. The inclusion of femoropopliteal DVT was reported as the main limitation of the trial by 55% of respondents. Despite half of the participating clinicians reporting no change in their clinical practice, equal number of clinicians (14%) were encouraged and discouraged from treating iliofemoral DVT. More than one-half of the respondents thought that the use of PCDT would be defensible in a court of law despite the increased risk of bleeding reported in the study. Nearly two-thirds of participating clinicians recommended performing a trial limited to iliofemoral DVT, with a follow-up period of 5 years, quality of life as the primary outcome measure, and standardization of thrombolysis protocol across the trial sites. Conclusions ATTRACT failed to provide the long-awaited indisputable evidence on the use of PCDT. Surveyed clinicians were aware of the limitations of this trial and the need for further evidence on the subject.

Graphical Abstract This online structured survey has demonstrated the global impact of the COVID-19 pandemic on vascular services. The majority of centres have documented marked reductions in operating and services provided to vascular patients. In the months during recovery from the resource restrictions imposed during the pandemic peaks, there will be a significant vascular disease burden awaiting surgeons. Graphical Abstract One of the most affected specialties

Objective This review aims to assess the evidence supporting the impact of patient foot care education on self efficacy, self care behaviour, and self care knowledge in individuals with diabetes. Methods This systematic review was registered prospectively on the PROSPERO database (CRD42019106171). Ovid EMBASE and MEDLINE databases were searched from 1946 to the end of March 2019, using search terms related to the domains diabetic foot, patient education, self efficacy, self care behaviour, and self care knowledge. All included studies were prospective, randomised controlled trials that assessed foot care education interventions in individuals with diabetes and recorded an outcome related to self efficacy, self care behaviour, and/or self care knowledge. Results Thirteen randomised controlled trials were included, reporting on a total of 3948 individuals. The risk of bias was high or unclear in 11 of the 13 included studies, and low in two studies. Both the education interventions delivered, and the outcome assessment tools used were heterogenous across included studies: meta-analysis was therefore not performed. Eight of 11 studies identified significantly better foot self care behaviour scores in individuals randomised to education compared with controls. Self efficacy scores were significantly better in education groups in four of five studies reporting this primary outcome. Foot care knowledge was significantly better in intervention vs. control in three of seven studies. In general, studies assessing secondary endpoints including quality of life and ulcer/amputation incidence tended not to identify significant clinical improvements. Conclusion The available evidence is of inadequate quality to reliably conclude that foot care education has a positive impact on foot self care behaviour and self efficacy in individuals with diabetes. Quality data supporting accompanying benefits on quality of life or ulcer/amputation incidence are also lacking and should be considered as an important outcome measure in future studies.