Associations between self-care advice and healing time in patients with venous leg ulcer- a Swedish registry-based study.

BACKGROUND: Venous leg ulcers take time to heal. It is advocated that physical activity plays a role in healing, and so does the patient's nutritional status. Additionally, malnutrition influences the inflammatory processes, which extends the healing time. Therefore, the staff's advising role is important for patient outcomes. Thus, this study aimed to investigate the associations between given self-care advice and healing time in patients with venous leg ulcers while controlling for demographic and ulcer-related factors. METHODS: The sample consisted of patients registered in the Registry of Ulcer Treatment (RUT) which includes patient and ulcer-related and healing variables. The data was analyzed with descriptive statistics. Logistic regression models were performed to investigate the influence of self-care advice on healing time. RESULTS: No associations between shorter healing time (less than 70 days) and the staff´s self-care advice on physical activity was identified, whilst pain (OR 1.90, CI 1.32-2.42, p < 0.001) and giving of nutrition advice (OR 1.55, CI 1.12-2.15, p = 0.009) showed an association with longer healing time. CONCLUSIONS: Neither self-care advice on nutrition and/or physical activity indicated to have a positive association with shorter healing time. However, information and counseling might not be enough. We emphasize the importance of continuously and systematically following up given advice throughout ulcer management, not only when having complicated ulcers.

Exploring the Association between Hemochromatosis and Lower-Limb Venous Disease.

OBJECTIVE: Chronic venous disease is a circulatory system dysfunction that has the potential to lead to venous leg ulceration. Although research on the influence of specific gene variants on chronic venous disease has been limited, a few studies have reported an association between hemochromatosis and chronic venous disease. However, no studies have looked at the prevalence of lower-limb venous disease and leg ulcers in people with hemochromatosis. This study aimed to review the existing literature for any association between venous disease and hemochromatosis and investigate the prevalence of venous disease and leg ulcers in people with hemochromatosis. METHODS: Scoping systematic literature review and cross-sectional study surveying people with hemochromatosis. RESULTS: This scoping systematic literature review included nine articles and indicated a link between hemochromatosis and venous disease/leg ulcers, although further studies are needed to support this link. Analysis of survey results from people with hemochromatosis found a 9.2% prevalence of leg ulcers in those with self-reported hemochromatosis, considerably higher than the 1% to 3% expected, suggesting that hemochromatosis gene variants may be associated with the pathogenesis of chronic venous disease and leg ulcers. CONCLUSIONS: This is the first known study to complete a review of the literature regarding hemochromatosis and venous leg ulcers and document the association between hemochromatosis and venous disease/leg ulcers. There is a lack of research in this area and hence limited evidence to guide practice.

Characteristics of chronic ulcer patients by gender and ulcer aetiology from a multidisciplinary wound centre.

Chronic ulcer patients form a heterogenous group of patients with various medical backgrounds. Cost-effective targeted treatment necessitates more knowledge about specific features related to different subgroups of ulcer patients. Hence, this study aimed to characterize ulcer patients according to gender and ulcer aetiology. A total of 946 consecutively recorded chronic ulcer patients in the Tampere Wound Registry (TWR) were included and data were gathered from the TWR and patient medical records. Comparisons were made between males and females and patients with venous-, arterial or mixed-, diabetic foot-, pressure- and atypical ulcers. Male patients were found to have diabetes, hypercholesterolemia and obesity significantly more often than females (59.2% vs. 39.6%; p < 0.001, 46.5% vs. 33.3%; p = 0.001, 42.7% vs. 35.9%; p = 0.017 respectively), whereas autoimmune diseases were more common among females (30.6% vs. 15.6%; p < 0.001). Recurrence of ulcers was most common among patients with venous ulcers (p < 0.001) and multimorbidity among those with diabetic foot ulcers (p < 0.001). To conclude, males with chronic ulcers would benefit particularly from lifestyle advice, multidisciplinary treatment should be targeted specifically at those with diabetic and arterial or mixed ulcers and preventive measures at those with venous ulcers.

Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers.

OBJECTIVE: To retrospectively evaluate the comorbidities, treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers (VLUs). METHOD: Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files were used to follow patients who received medical care for a VLU between 1 October 2015 and 2 October 2019. Patients diagnosed with chronic venous insufficiency (CVI) and a VLU were propensity matched into four groups based on their treatment regimen. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs, as well as important outcomes, such as time to ulcer closure, rates of complications and hospital utilisation rates. Outcomes were compared across key propensity-matched groups. RESULTS: In total, 42% of Medicare enrolees with CVI (n=1,225,278), developed at least one VLU during the study, and 79% had their episode claim completed within one year. However, 59% of patients developed another VLU during the study period. This analysis shows that only 38.4% of VLU episodes received documented VLU conservative care treatment. Propensity-matched episodes that received an advanced treatment or high-cost skin substitutes for a wound which had not progressed by 30 days demonstrated the best outcomes when their cellular, acellular, matrix-like product (CAMP) treatment was applied weekly or biweekly (following parameters for use). Complications such as rates of infection (33%) and emergency department visits (>50%) decreased among patients who received an advanced treatment (following parameters for use). CONCLUSION: Medicare enrolees with CVI have diverse comorbidities and many do not receive sufficient management, which contributes to high rates of VLUs and subsequent complications. Medicare patients at risk of a VLU who receive early identification and advanced CAMP treatment demonstrated improved quality of life and significantly reduced healthcare resource utilisation.

Prevalence and incidence of venous leg ulcers-A systematic review and meta-analysis.

Venous leg ulcers (VLU) represent a major public health challenge. Little is known about the prevalence and incidence of VLU internationally. Published studies are usually reporting different estimates because of disparities in study designs and measurement methods. Therefore, we conducted a systematic literature review and meta-analysis to identify the prevalence and incidence of VLU internationally and to characterise the population as reported in these studies. Studies were identified from searches in Medline (PubMed), CINAHL Complete (EBSCOhost), Embase, Scopus, Web of Science, LiSSa (Littérature Scientifique en Santé), Google Scholar and Cochrane Database of Systematic Reviews up to November 2022. Studies were included if their primary outcomes were reported as a period prevalence or point prevalence or cumulative incidence or incidence VLU rate. Fourteen studies met the inclusion criteria, 10 reporting estimates of prevalence, three reporting both prevalence and incidence estimates and one incidence. All were included in meta-analyses. The results show a pooled prevalence of 0.32% and a pooled incidence of 0.17%. Our results highlighted an extreme heterogeneity across effect sizes for both prevalence and incidence, which prevent a meaningful interpretation of pooled indexes and argue for further studies with specific prevalence-type reported and target population under study.

What is the prevalence of chronic venous disease among health care workers? A scoping review.

Chronic venous disease (CVD) occurs because of structural or functional disturbances to the venous system of the lower limbs. Signs and symptoms include leg pain, swelling, varicose veins, and skin changes, with venous ulceration ultimately occurring in severe disease. To assess the prevalence of CVD among health care workers, a scoping review of existing publications exploring the prevalence of CVD among health care workers was conducted in July 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used. A total of 15 papers met the inclusion criteria and these formed the basis of the review. Among health care workers, the mean prevalence of CVD was 58.5% and the mean prevalence for varicose veins was 22.1%. There is an increased prevalence of CVD in health care workers when compared with the general population. Therefore, there is a need for early diagnosis and the use of preventative measures to protect health care workers from CVD and varicose vein development.

Elevated serum homocysteine levels are associated with the development of chronic venous ulcers.

INTRODUCTION: Venous ulceration is a multifactorial disease, and whether hyperhomocysteinemia (HHcy) promotes deterioration from primary varicose veins to venous ulcers remains unproven. METHODS: This study retrospectively analyzed clinical data from 717 patients to investigate the potential correlation between HHcy and primary varicose veins ulcer formation, including 611 patients without ulcers (control group) and 106 with ulcers (case group). RESULTS: In this study, 46.2% (49/106) of patients in the case group and 17.5% (107/611, p < 0.001) in the control group suffered from HHcy. Multivariate logistic analysis revealed that HHcy was closely associated with the incidence of venous ulceration in patients with primary varicose veins (p < 0.001). Propensity score matching created 101 matched pairs of patients with and without ulcers, and the analysis pointed to a potential link between HHcy and ulcer formation in the context of primary varicose veins (p < 0.001). Additional experiments showed that HHcy could induce endothelial dysfunction and phenotypic switching of vascular smooth muscle cells. CONCLUSION: Both clinical and experimental findings implicated HHcy as a key factor in the development of venous ulceration. Further research is needed to appraise the effectiveness of HHcy-lowering therapy in the prevention of venous ulcers in patients with varicose veins.

An estimate of the economic burden of venous leg ulcers associated with deep venous disease.

INTRODUCTION: Venous leg ulcers (VLU) embody the most severe stage of the broad spectrum of chronic venous disease. Approximately 40% of patients with VLU present with the underlying deep venous disease (DVD). Although the data are scarce, these deep venous disease-related VLU (DRV) are thought to have higher recurrence rates and a substantial economic burden. The objective of this study was to assess the economic burden of DRV across Australia, France, Germany, Italy, Spain, the UK, and the USA. METHODS: A comprehensive literature review was undertaken to identify publications documenting the incidence and prevalence of VLU and DRV, medical resource utilization, and associated costs of DRV. Findings from this literature review were used to estimate the economic burden of illness, including direct medical costs over a 12-month interval following initial presentation of a newly formed DRV. RESULTS: Total annual incidence of new or recurrent DRV in Australia, France, Germany, Italy, Spain, UK, and the US are estimated at 122,000, 263,000, 345,000, 253,000, 85,000, 230,000, and 643,000 events, respectively, in 2019. Incidence ranges from 0.73 to 3.12 per 1000 persons per year. The estimated annual direct medical costs for patients managed conservatively in these geographies total ~ $10.73 billion (USD) or $5527 per person per year. CONCLUSION: The availability of published data on the costs of VLU care varies widely across countries considered in this analysis. Although country-specific VLU practice patterns vary, there is a uniform pattern of high-cost care.

A point prevalence audit of inpatients with leg ulcers eligible for compression therapy in a large university NHS hospital.

OBJECTIVE: Compression therapy is the mainstay of treatment for venous leg ulceration. Several studies have evaluated leg ulcer management and compression in the community. However, little is known about the leg ulcer population and use of compression therapy in the hospital setting, where it is not often part of inpatient care. This study aimed to evaluate the proportion of inpatients with leg ulceration eligible for compression therapy. METHOD: A point prevalence audit was undertaken using three methods: patient electronic live report; a leg ulcer audit form; and an electronic record search. The following data were retrieved: patient age, sex, primary reason for admission, diabetes, mobility status, history of dementia, Clinical Frailty Scale score and presence of oedema. Ankle-brachial pressure index was measured to determine patients' eligibility for compression therapy. RESULTS: The audit identified 80/931 (8.5%) inpatients as having confirmed, active leg ulceration. A total of 36/80 (45%) inpatients were assessed for eligibility for compression, of whom 25/36 (69.4%) were eligible for full compression, 2/36 (5.6%) reduced compression and 9/36 (25%) were not eligible for compression therapy. CONCLUSION: The audit demonstrated that a significant proportion of hospital inpatients with leg ulcers were eligible for compression therapy and that this patient population were heterogenous in terms of comorbidity profile, mobility, frailty and dementia, among other factors. Further research is required to explore the most feasible and effective compression options for inpatients with leg ulcers.

Bacteria and bioburden and healing in complex wounds: A prognostic systematic review.

The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the wound microbiome are independent prognostic factors for the healing of complex wounds. We searched Medline, Embase, CINAHL and the Cochrane Library to February 2019. We included longitudinal studies which assessed the independent association of aspects of wound microbiome with healing of complex wounds while controlling for confounding factors. Two reviewers extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. We synthesised studies narratively due to the clinical and methodological heterogeneity of included studies and sparse data. We identified 28 cohorts from 21 studies with a total of 38,604 participants, including people with diabetes and foot ulcers, open surgical wounds, venous leg ulcers and pressure ulcers. Risk of bias varied from low (2 cohorts) to high (17 cohorts); the great majority of participants were in cohorts at high risk of bias. Most evidence related to the association of baseline clinical wound infection with healing. Clinical infection at baseline may be associated with less likelihood of wound healing in foot ulcers in diabetes (HR from cohort with moderate risk of bias 0.53, 95% CI 0.33 to 0.83) or slower healing in open surgical wounds (HR 0.65, 95% CI 0.51 to 0.83); evidence in other wounds is more limited. Most other associations assessed showed no clear relationship with wound healing; evidence was limited and often sparse; and we documented gaps in the evidence. There is low certainty evidence that a diagnosis of wound infection may be prognostic of poorer healing in foot ulcers in diabetes, and some moderate certainty evidence for this in open surgical wounds. Low certainty evidence means that more research could change these findings.

Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real-World Data Analysis.

PURPOSE: The aim of this study was to evaluate the validity of lower limb chronic venous disease (CVD) diagnoses entered in a large electronic health record database in primary care in Catalonia, Spain; to investigate the reliability of these data for research purposes; and to estimate the prevalence and incidence of CVD, chronic venous insufficiency (CVI), and venous leg ulcer (VLU). DESIGN: Real-world data analysis based on a large electronic health record database in primary care in Catalonia, Spain. METHODS: We used a primary care research database (Information System for the Development of Research in Primary Care [SIDIAP]), which contains anonymous data on some 5.8 million people from 279 primary care centers, accounting for more than 80% of the Catalonian population and 15% of the Spanish population. We evaluated the validity of the ICD-10 codes for CVD in SIDIAP for 200 adult patients through the responses of 20 primary care physicians to a questionnaire. FINDINGS: The positive predictive value of CVD in SIDIAP was 89.95% (95% confidence interval [CI] 84.99-93.40). The prevalence rates for CVD, CVI, and VLU were 9.54% (95% CI 9.51-9.56), 3.87%, and 0.33%, respectively. The incidence rates for CVD, CVI, and VLU were 7.91/1,000 person-years (95% CI 7.82-8.00), 3.37/1,000 person-years (95% CI 3.31-3.43), and 0.23/1,000 person-years (95% CI 0.21-0.24), respectively. CONCLUSIONS: The Catalonian SIDIAP database contains valid CVD diagnoses. The prevalence and incidence rates found using real-world data are low compared with those in the literature, possibly because CVD is an underdiagnosed entity. CLINICAL RELEVANCE: Real-world data can inform clinicians on lower limb venous health in a population, show changes as individuals age, and reveal aspects where healthcare can be improved.

The profile of patients with venous leg ulcers: A systematic review and global perspective.

BACKGROUND: A holistic profile that includes demographic, medical history and wound characteristics of individuals with venous leg ulceration is lacking. Lack of such a profile negatively impacts the ability to develop interventions to improve patient outcomes. OBJECTIVES: To describe the profile of the patient population with venous leg ulceration from published observational (non-interventional) studies and to identify gaps in the knowledge base for future research in this area. METHODS: A systematic review of observational studies that included more than 50 patients, from any world region, of any age and in any care setting. RESULTS: twenty studies, involving 3395 patients, from all world regions met our criteria. Demographic characteristics were well reported and showed a female to male ratio of 1.2:1, average age of 47-65 years, high levels of co-morbidities including hypertension (53-71%) and diabetes (16-20%), and only one study reporting ethnicity. When reported, approximately 4-30% had high levels of depression. The average wound size was 18.6-43.39 cm2; mean wound duration was 13.8-65.5 months, mean number of recurrences was four. No study reported on demographic factors plus medical history plus wound characteristics together. CONCLUSION: a comprehensive, holistic profile of the population with VLU is lacking. There is a critical need for more comprehensive profiling to enable the development of targeted interventions to improve outcomes.

Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound. DESIGN: A 6-month randomized controlled trial. SUBJECTS AND SETTING: The target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American. METHODS: Participants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages. RESULTS: One hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo. CONCLUSIONS: While the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.

A qualitative study on the patient's narrative in the progression of chronic venous disease into a first venous leg ulcer: a series of events.

BACKGROUND: A venous leg ulcer (VLU) has a significant negative impact on quality of life. Prevention of a VLU is not yet imbedded in clinical practice because risk factors for developing a first VLU are not well known. OBJECTIVES: To explore further the progression of chronic venous disease (CVD) into a first VLU from the patient's perspective. METHODS: A qualitative study using semistructured interviews was conducted among male and female patients with a VLU. Patients from primary and secondary care, under and over 50 years of age, and with first and recurrent VLUs were included. The interviews were transcribed and analysed using a narrative approach to a thematic analysis. Transcripts were organized in chronological order and an iterative process was used to code the transcripts. RESULTS: Four key themes and the connections made between them emerged from the 11 narratives on the progression of CVD towards a first VLU: 'comorbidity', 'mobility', 'work and lifestyle' and 'acknowledgment of CVD'. Comorbidity was linked to reduced mobility and late acknowledgment of CVD. Comorbidity also affected work and lifestyle and vice versa. Work and lifestyle affected mobility and was linked to the acknowledgment of CVD. CONCLUSIONS: A reduction in mobility as a result of comorbidity and work and lifestyle occurred before the VLU developed. Patients did not recognize symptoms of CVD and did not acknowledge the chronicity of CVD. Healthcare professionals should be aware of reductions in mobility and the knowledge deficit in patients with CVD. What's already known about this topic? Not all patients with chronic venous disease (CVD) develop a venous leg ulcer (VLU). A patient's quality of life decreases significantly when a VLU develops. Risk factors for the development of a first VLU in patients with CVD are not well known, unlike risk factors for other chronic wounds like diabetic foot ulcer and pressure ulcers. What does this study add? The patient's narrative towards the development of a first VLU, a series of events. Insight into the events (comorbidity, mobility, work and lifestyle) that patients themselves link to the development of a VLU. Insight into the patients' acknowledgment of CVD in the progression of CVD towards a first VLU. What are the clinical implications of this work? More awareness is needed of CVD symptoms among patients and healthcare providers, as well as more awareness for prevention of a VLU in clinical practice. New insights (for further studies) are needed into the concept of mobility and the development of a VLU. Improved patient education and follow-up are needed for patients with CVD.

Does localized iron loss in venous disease lead to systemic iron deficiency? A descriptive pilot study.

Haemosiderin deposition in the legs of patients with venous leg ulcers is well established, and several theories suggest this stored iron has a role in disease pathophysiology. In this novel pilot study of patients with chronic venous leg ulcers, we aimed to establish the relationship between wound fluid iron levels, serum iron parameters and healing. Fifteen patients with venous ulcers were included in the study. Blood samples were taken for full blood count and iron studies, while simultaneously wound fluid was obtained from the wound surface using filter paper. Wound areas were measured at initial and 4 week (+/- 2 day) follow-up visits. We found a positive correlation between wound fluid and serum iron (correlation co-efficient 0.27) and those with the lowest wound fluid iron level were also anemic. No association was found between initial wound area and wound fluid iron level but the largest wound areas were found in patients with anemia. Only 38% of patients demonstrated a reduction in wound area during the 4 week study, and 80% of those were not anemic or iron deficient. Conversely in those patients whose wounds did not reduce in size 88% were anemic or iron deficient. These findings demonstrate a previously unrecognized phenomenon of systemic iron store depletion secondary to leaching out of the body in wound exudate. In addition, these results suggest a high prevalence of anemia in patients with chronic venous ulcers, though whether this is cause or effect requires further research. Our findings also suggest that patients with venous ulcers have a high prevalence of iron deficiency and anemia, which appears to be often undiagnosed, and that diagnostic criteria for iron deficiency in patients with chronic wounds need to be revised to reflect the effect of chronic inflammation on iron metabolism.

Dietary supplement use by older adults with chronic venous leg ulcers: A retrospective, descriptive study.

Nearly 70% of older adults in the U.S. report using ≥1 dietary supplements (DSs) daily. While DSs may have health benefits, there is risk for toxicity or harmful drug-supplement interactions if not taken correctly. Older adults with chronic wounds who use DSs are at increased risk of adverse drug-supplement interactions because they usually have comorbidities requiring polypharmacy management. However, no studies have evaluated DS use in this population. The aim of this retrospective pilot study was to describe DS use by a sample of older adults (n = 40) with chronic venous leg ulcers (CVLUs) who participated in a clinical trial testing the effects of fish oil supplementation on wound healing. At baseline, study personnel assisted all participants in completing an electronic questionnaire about DS use. Descriptive statistics were used to characterize the data. Twenty-five of the 40 participants (62.5%) reported taking ≥1 DS daily. On average, DS users were 65.16 years (SD = 8.51) and the majority were men (64.0%), white (68.0%), and had at least some college education (72.0%). Fifteen (60.0%) reported taking 1-2 DSs/day, and 10 (40.0%) reported taking ≥3/day. The most frequently reported DSs used were multivitamin/mineral complex (60.0%), vitamin D (36.0%), vitamin B complex (28.0%) and calcium (28.0%). Reasons for using DSs were to maintain or improve health (44.0%), improve bone density (12%), and boost the immune system (12%). Supplement users reported consuming an average of 9.12 (SD = 6.46) prescription drugs daily and 21 (84.0%) reported ≥3 chronic health conditions. In summary, DS use in this sample of chronic wound patients was high. Moreover, DS users reported using multiple prescription drugs (2-23/day) concomitantly with DSs. While older adults with CVLUs may benefit from targeted DS therapy, monitoring their DS use to reduce risk for adverse drug-supplement interactions is best practice.

Two-layer reduced compression system for lower limb wounds: a non-comparative evaluation.

Leg ulceration is a debilitating condition in which various factors play a role in determining patients' quality of life (QoL), and compression therapy has been shown to improve QoL. The 3M Coban 2 Lite Compression System provides reduced compression (25-30 mmHg) ideal for patients with painful venous leg ulcers (VLU) who are unable to tolerate high-strength compression or those with mixed-aetiology leg ulcers (MLU) who have an ankle-brachial pressure index (ABPI)≥0.5. This non-comparative evaluation aims to report the initial clinical experiences with 3M Coban 2 Lite and evaluate the performance of this two-layer reduced compression bandage system in treating chronic VLUs and MLUs. In total, 30 patients (12 men (40%); mean age=68.5 years) were enroled for evaluation. The duration of the chronic wounds was 28 months (range=1.5-144 months); 16 patients had VLUs, while 14 had MLUs. Complete healing was achieved in 6 (20%) patients, and an overall mean reduction in wound surface area (4.11 cm2) was observed between the baseline and study endpoint (16 weeks). Thus, 3M Coban 2 Lite seems safe and effective for treating painful VLUs and MLUs in patients unable to tolerate high-strength compression.

External validity of randomized controlled trials of interventions in venous leg ulceration: A systematic review.

We set out to evaluate quality of reporting of data related to external validity from randomized controlled trials (RCTs) assessing treatment interventions for active venous leg ulcers. Using a systematic review study design, we identified 144 full-text RCTs of treatment interventions, where the wound was assessed and published in English from 1998 to 2018. We found that the median study sample size was 75.5. Weighted mean wound size was 13.22 cm2 and weighted mean wound duration was 22.20 months. Forty-six (32%) reported numbers screened for eligibility and 27 (19%) reported the number who declined to participate; 19 (13%) reported on patient ethnicity; 60 (42%) reported comorbidities; and 5 (4%) reported current medication use. When reported, 60/102 (59%) excluded patients with an ankle-brachial pressure index <0.8; 68/135 (50%) were conducted in Europe, 6/135 (4%) in Asia, and 74/104 (71%) were conducted in outpatient facilities; 3 (2%) reported socioeconomic factors and 88 (61%) reported on adverse events. We concluded that there is inadequate reporting of data related to external validity in reports of RCTs assessing venous leg ulcers treatment interventions. Significant variability exists in the ankle-brachial pressure index cutoff point for inclusion or exclusion, making generalizability difficult to assess.

A systematic review on risk factors in developing a first-time Venous Leg Ulcer.

Venous Leg Ulcers (VLU) occur in about 1% of the Western population. A VLU takes 3-12 months to heal, it recurs often, and it has a negative impact on the quality of life. The risk factors for the development of a first VLU are not well-understood and prevention of a first VLU therefore remains underappreciated. The aim of this study was to identify risk factors for developing a first VLU in adults (aged > 18 years) by searching the literature. We searched the Cochrane Library, Pubmed, Cinalh and Narcisto identify studies that investigated risk factors in developing a VLU. The last search was performed in January 2018. Two reviewers independently reviewed the abstracts and full-text articles, and assessed the methodological quality of the included studies. Results of studies using duplex scanning, and comparing participants with and without VLUs were included in the qualitative analysis. Where possible a quantitative meta-analysis was conducted. We found five studies that investigated the relation of several risk factors with VLU development. The methodological differences of the studies made it impossible to perform a quantitative analysis. The risk factors higher age (four studies), higher body mass index (four studies), low physical activity (four studies), arterial hypertension (four studies), deep vein reflux (three studies), deep venous thrombosis (three studies) and family history of VLU (three studies) were significantly associated with a VLU in the majority of the studies. To what extent they influence the development of a VLU remains unclear because of the limited number of studies that investigated the association of these risk factors with VLU development, and the heterogeneity of these studies. Further studies are needed to confirm the association of these risk factors with the development of a VLU and to explore overweight and low physical activity in more detail.

Epidemiology of venous leg ulcers in primary health care: Incidence and prevalence in a health centre-A time series study (2010-2014).

The aims of the study were to describe and analyse the temporal trend of the prevalence and incidence of venous leg ulcers (VLU) over the years 2010 to 2014, to determine healing times and temporal trends in the study period, and to evaluate related aspects such as the use of the Ankle-Brachial Pressure Index (ABPI) in a primary care health centre. This was a retrospective study based on a time series (years 2010-2014) of the prevalence and incidence of VLUs in people aged over 40 years in a primary care centre in Barcelona City. We reviewed 3920 electronic health records selecting patients, per year (2010-2014), with VLUs based on the ICD-10 diagnoses. For prevalence, we took into account any patient with an active VLU in the year of study. For incidence, we took into account patients with a new VLU in the year of study. A descriptive analysis was carried out based on each of the collected variables. The variables were examined according to the years of study (time series) by one-factor analysis of variance (anova) or Kruskal-Wallis non-parametric test, as appropriate. A survival analysis by Kaplan-Meier curves and log-rank test was also performed. A total of 139 patients met the VLU criteria. Among them, only 79.2% were classified as having a VLU and had a correct ICD diagnosis. The prevalence and incidence increased over the years, doubling in patients aged over 65 years. Incidence increased from 0.5 new cases per 1000 people/year in 2010 to 1 new case for every 1000 people/year in 2014. Moreover, the prevalence ranged between 0.8 and 2.2 patients with VLU for every 1000 people/year. During the study period, a total of 84.2% of the VLUs healed (117/139 VLU). Regarding average annual time to healing, the trend indicates that lesions took less time to heal (Kruskal-Wallis test, P = 0.004), ranging between 453,9 weeks in 2005 to 19 weeks in 2014. The use of ABPI also evolved and was found to be increasingly performed prior to the appearance of the lesion. The epidemiological profile of people affected by VLUs continues to be, mainly, that of women of an advanced age, over 70 years. The frequency of VLU occurrence rose continually over the years, but healing took less time, and use of ABPI improved. Assigning a reference nurse in the wounds unit and the organisational structure around this problem may have an influence on improving care and the approach to these types of lesions.