The combination of hyaluronic acid and collagenase in the treatment of skin ulcers: an open, multicenter clinical study assessing safety and tolerability of Bionect Start®.

OBJECTIVE: Several clinical studies have shown that hyaluronic acid collagenase is well-tolerated and very effective in managing chronic venous ulcers. The aim of the present study is to confirm the safety and tolerability of daily application in patients suffering from cutaneous ulcers of different etiologies. The efficacy of the treatment and its impact on patients' quality of life are also assessed. PATIENTS AND METHODS: Patients with a clinical diagnosis of skin ulcer with devitalized/fibrinous/slough tissue that could delay the healing process were enrolled in the study. The hyaluronic acid/collagenase ointment was applied topically until wound closure or total debridement of non-viable tissue was achieved, however, with a limit of 30 days. Monitoring was performed weekly, either through outpatient visits or telephone surveys. Assessments included adverse events, local irritation reactions, pain at dressing changes, and wound bed status. Patients were also requested to complete a quality-of-life questionnaire. RESULTS: The study involved 96 patients with a mean age of 71 years. The patients suffered mainly from traumatic (21.9%), venous (15.6%), or pressure ulcers (12.5%); in 26% of cases, ulcers had mixed etiology. In approximately 32% of patients, the ulcer had been present for more than 6 months, and 18.1% of subjects had previously undergone surgical wound debridement. CONCLUSIONS: Daily application of hyaluronic acid-collagenase achieved the following results: i) absence of adverse events related to the use of the product; ii) significant reduction in the degree of localized irritation and pain at dressing changes; iii) significant support to wound bed preparation; iv) trend towards improvement in the quality of life and health status of the patients.

Tratamiento crónico ambulatorio con sevoflurano tópico en pacientes con úlceras vasculares / Chronic outpatient treatment with topical sevoflurane in patients with vascular ulcers

Objetivo mostrar la efectividad y seguridad del sevoflurano tópico tras la administración ambulatoria y prolongada en los pacientes con úlceras vasculares refractarias. Métodos estudio observacional retrospectivo de pacientes con úlceras vasculares dolorosas refractarias a terapias habituales y que fueron tratados con sevoflurano tópico durante al menos 36 meses. Se recogieron las variables: edad, sexo, antecedentes médicos, comorbilidad asociada, etiología de úlcera y tratamiento médico. Se analizó la mejoría clínica y la variación de la superficie de las úlceras vasculares. Para cuantificar la intensidad del dolor basal e irruptivo antes y después del tratamiento se utilizó la escala visual analógica. Resultados del total de pacientes tratados, 9 cumplían los criterios de inclusión. La edad media fue de 74,8 ± 7,5 años. Los casos 2 y 9 fallecieron durante el seguimiento. La acción analgésica del sevoflurano tópico fue rápida (3,1 ± 2,1 min), intensa (escala visual analógica: 7 ± 1,1 a 1,4 ± 1,1 puntos) y duradera (de 6 a 24 h). Salvo el caso 4, todos experimentaron una reducción de la superficie (15,1 ± 5,0 a 2,7 ± 4,2) de las úlceras vasculares y no se observó tolerancia a lo largo del tiempo. Conclusión la aplicación de sevoflurano tópico es una estrategia analgésica y reepitelizante para las úlceras vasculares que presenta un perfil correcto de seguridad (AU)

Objective To show the effectiveness and safety of topical sevoflurane after ambulatory and prolonged administration in patients with refractory vascular ulcers. Methods Retrospective observational study analyzing clinical improvement and vascular ulcers surface area variation after topical application of sevoflurane. Inclusion criteria were patients with painful vascular ulcers refractory to usual therapies and who were treated with topical sevoflurane for at least 36 months. The following variables were collected: age, sex, medical history, associated comorbidity, ulcer etiology and medical treatment. The visual analog scale was used to measure baseline and break through pain intensity before and after treatment. Results Nine patients met the inclusion criteria of the total number of patients treated whose median age was 74.8 ± 7.5 years. Cases 2 and 9 died during follow-up. In all cases, the analgesic action of topical sevoflurane was rapid (3.1 ± 2.1 minutes), intense (visual analog scale: 7 ± 1.1 to 1.4 ± 1.1 points) and long-lasting (6 to 24 h). With the exception of case 4, all patients experienced a large reduction in vascular ulcers surface area (15.1 ± 5.0 a 2.7 ± 4.2) and tolerance was not observed over time. Conclusion Topical application of sevoflurane is an analgesic and re-epithelializing strategy for vascular ulcers with a successful safety profile (AU)

Healing of Venous Leg Ulcers Influenced by Individual Aspects: Cluster Analysis in a Specialist Wound Management Clinic.

INTRODUCTION/OBJECTIVE: Venous Leg Ulcers (VLU) present a challenging healing process. Attaining healing is a primary treatment objective, commonly pursued in Primary Health Care (PHC) or Specialist Wound Management Clinics. Our objective was to examine the association and interplay between sociodemographic, health, clinical, and care factors with the outcomes of VLU treatment in patients undergoing care at a Specialist Wound Management Clinic. METHODS: Longitudinal, observational study took place in a center for the treatment of chronic injuries linked to PHC. The sociodemographic aspects, health status and habits, clinical and care aspects of patients with VLU were scrutinized over a 1-year period. RESULTS: The sample comprised 103 participants, with some still under treatment (Treatment Group-TG/ n = 60) and others having achieved VLU healing (Healing Group-HG/ n = 43). An association between sociodemographic, health, clinical, and care factors and the healing outcome (HG) was identified. A moderate correlation was observed between factors predisposing to healing in the sociodemographic group and health habits. Notably, among sociodemographic factors, the older age group and improvements in health, particularly the reduced use of alcohol/smoking, appeared to exert the most significant influence on healing. Additionally, specialized service monitoring and the application of compression therapy were contributory factors. CONCLUSIONS: These findings substantiate the hypothesis that sociodemographic, health, clinical, and care-related aspects are intertwined with VLU healing. Protective factors associated with healing interacted synergistically, fostering a positive outcome over one year of treatment.

Cost-effectiveness of ChloraSolv in treating hard-to-heal venous leg ulcers.

OBJECTIVE: To estimate whether the topical, amino acid-buffered hypochlorite debriding gel ChloraSolv (RLS Global AB, Sweden) could potentially afford the UK's health services a cost-effective intervention for hard-to-heal venous leg ulcers (VLUs). METHOD: A Markov model representing the management of hard-to-heal VLUs with ChloraSolv plus standard care (SC) or SC alone was populated with inputs from an indirect comparison of two propensity score-matched cohorts. The model estimated the relative cost-effectiveness of ChloraSolv in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2021/2022 prices. RESULTS: Addition of ChloraSolv to an SC protocol was found to increase the probability of healing by 36% (from 0.14 to 0.19) after 12 weeks, and by 79% (from 0.24 to 0.43) after 24 weeks. This led to a marginal increase in health-related quality of life. Treatment with ChloraSolv plus SC instead of SC alone reduced the total cost of wound management by 8% (£189 per VLU) at 12 weeks and by 18% (£796 per VLU) at 24 weeks. Use of ChloraSolv was estimated to improve health outcomes at reduced cost. Sensitivity analysis showed that use of ChloraSolv plus SC remained a cost-effective treatment with plausible variations in costs and effectiveness. CONCLUSION: Within the limitations of the study, the addition of ChloraSolv to an SC protocol potentially affords a cost-effective treatment to the UK's health services for managing hard-to-heal VLUs.

The Potential of Bacteriophage Therapy as an Alternative Treatment Approach for Antibiotic-Resistant Infections.

OBJECTIVE: This study aimed to provide a comprehensive overview of the current state of the literature on the therapeutical application of bacteriophages. METHODS: First, a bibliometric analysis was performed using the database Web of Science to determine annual number of publications and citations. Second, a systematic literature review was conducted on randomized-controlled trials (RCTs) of phage therapy in PubMed. RESULTS: Over the past decade, the number of publications on bacteriophage therapy increased more than fourfold with 212 articles in 2011 and 739 in 2022. The systematic search in PubMed yielded 7 RCTs eligible for inclusion, reporting on a total of 418 participants. Identified indications in this study included bacterial diarrhea, urinary tract infections, infected burn wounds, chronic otitis, chronic venous leg ulcers, and chronic rhinosinusitis. In three studies, mild to moderate adverse events were reported in 10/195 participants (5.1%). Three of the studies reported a statistically significant difference in outcomes comparing phage therapy with standard of care or placebo. CONCLUSION: Phage therapy has gained increasing interest over the years. RCTs on different indications suggest the safety of phage therapy; however, reasons why phage therapy is not yet well accepted are limitations in the study designs. For a successful translation into clinical practice researchers and clinicians should learn from the earlier experiences and consider issues such as the quality of phage preparation, sensitivity testing, titer and dosages, as well as access to the infection site and stability for standardized protocols and future trials.

Testing the feasibility of a co-designed intervention, comprising self-managed, home-based, exercise training with embedded behavioural support and compression therapy for people with venous leg ulcers receiving treatment at home (FISCU-II).

BACKGROUND: Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients' quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. OBJECTIVES: To assess the feasibility of 'FISCU Home' (a co-designed, 12-week home-based self-managed lifestyle programme based on exercise and behaviour support) as an adjunct therapy to compression in people with VLUs. METHODS: Forty people with VLUs, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events (AEs). Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e. ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. RESULTS: The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) ulcer healing time was shorter in the exercise group [29 (7-108) vs. 42 (6-116) weeks]. CONCLUSIONS: The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported.

Cost-effectiveness analysis of intralesional and perilesional recombinant human epidermal growth factor vs hydrocolloid therapy in venous ulcer treatment in the Colombian context.

OBJECTIVE: To perform a comparative analysis of health care expenses and outcomes in response to the question: What is the cost-effectiveness of intralesional and perilesional recombinant human epidermal growth factor (rhEGF) compared with hydrocolloid therapy in patients diagnosed with chronic venous insufficiency without infection in Colombia? METHODS: A Markov model was used to determine cost effectiveness over a 5-year period, considering the perspective of the health system in Colombia. The study included patients aged >18 years diagnosed with chronic venous insufficiency and used clinical studies to calculate the probabilities of epithelialization, infection, recurrence, and mortality. RESULTS: RhEGF is more expensive per unit than hydrocolloids, but it is proven to be effective at healing ulcers in 8 to 12 weeks, even in complex cases. Hydrocolloids, in contrast, typically require 29.5 weeks on average, and ≤46 weeks for complex cases. Despite the cost, rhEGF is more cost effective because it achieves results comparable with hydrocolloid therapy at a lower cost per additional quality-adjusted life-year. CONCLUSIONS: Based on cost-effectiveness analysis, rhEGF is a superior alternative to hydrocolloids for treating venous ulcers in Colombia. Not only is it more affordable, but it also enhances patients' quality of life and streamlines the health care system's resource use.

Application of StyleGAN Architecture for Generating Venous Leg Ulcer Images.

Leg ulcers caused by impaired venous blood return are the most typical chronic wound form and have a significant negative impact on the lives of people living with these wounds. Thus, it is important to provide early assessment and appropriate treatment of the wounds to promote their healing in the normal trajectory. Gathering quality wound data is an important component of good clinical care, enabling monitoring of healing progress. This data can also be useful to train machine learning algorithms with a view to predicting healing. Unfortunately, a high volume of good-quality data is needed to create datasets of suitable volume from people with wounds. In order to improve the process of gathering venous leg ulcer (VLU) data we propose the generative adversarial network based on StyleGAN architecture to synthesize new images from original samples. We utilized a dataset that was manually collected as part of a longitudinal observational study of VLUs and successfully synthesized new samples. These synthesized samples were validated by two clinicians. In future work, we plan to further process these new samples to train a fully automated neural network for ulcer segmentation.

Evaluation of factors affecting the healing process of venous ulcers: A 12-week longitudinal study.

The process of healing venous ulcers is complex and influenced by many factors. By identifying the risk factors that influence a slower healing process, it is possible to predict impending delays and plan an individualised care plan. We analysed our database of patients with venous ulcers and identified clinical and demographic factors that delay the healing process. The research analysed the medical records of 754 patients with VLUs at Chronic Wound Treatment Unit of the University Hospital treated between 2001 and 2019. In study, the majority (64.3%) were women, the mean age was 65.7 years. The median duration of Chronic Venous Insufficiency was 24 years, 52% patients had had the disease >20 years, and 296 (39.3%) had experienced ulceration >12 months. Most of the patients (85.8%) had comorbidities, 84% were obese. At 12-week follow-up, 432 of the 754 ulcers had healed. Identified independent predictors of slower ulcer healing rates: wound area greater than 8.25 cm2 , location of the ulceration other than the medial ankle area, underlying disease >20 years, the presence of multiple comorbidities, depth of the ulcer, the presence of an unpleasant smell and alert pathogens. The presence of redness resulted in faster healing of VLUc. Many factors influence the healing process of venous ulceration. The results of the study can help in planning patient care and implementing appropriate early strategies to promote healing.

Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures.

OBJECTIVE: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). METHOD: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. RESULTS: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60-253) days in the MCB group versus 137 (IQR: 68-300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. CONCLUSION: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.

A simple index to predict healing in venous leg ulcers: a secondary analysis from four randomised controlled trials.

OBJECTIVE: To investigate whether the use of a simple baseline measurement predicts venous leg ulcer healing at 12 and 24 weeks. METHOD: This was a secondary analysis of a cohort of four randomised controlled trials (RCTs) of treatments adjuvant to compression. Self-reported ulcer duration, and measured ulcer length and width, to calculate estimated ulcer area, were used to obtain a Margolis index score. The score created three prognostic strata for likelihood to heal within 24 weeks, and the number of participants healed and time-to-healing were compared. RESULTS: There were a total of 802 participants across the four RCTs-408 (50.9%) in two 12-week trials and 394 (49.1%) in two 24-week trials. The mean age of participants was 63.7±17.6 years, and 372 were female (46.4%). The Margolis index score at baseline was 0 for 320 participants (predicted normal healing); 1 for 334 participants; and 2 for 148 participants (both 1 and 2 predicted slow-to-heal). Overall, 248 (77.5%) of those participants who scored 0 at baseline healed within 24 weeks, compared with 182 (54.5%) of participants who scored 1, and 30 (20.3%) participants who scored 2. The median time-to-healing was 40 (24-62) days, 57 (35-100) days and 86.5 (56-151) days, respectively. The area under the receiver operating characteristic curve was 0.69 and 0.77, respectively, for the 12 and 24 week trials. CONCLUSION: A simple baseline index identifies participants with normal or slow-to-heal wounds and could be used to demonstrate prognostic balance between treatment groups in trials. This approach could also be used in clinical practice to assist with managing expectations and for early identification of patients who may best benefit from adjuvant treatments.

Use of Intralesional and Perilesional Human Recombinant Epidermal Growth Factor (hrEGF) in the Local Treatment of Venous Ulcer - Review Article - Expert Recommendation.

Venous Ulcers (VU) represent 60-80% of all leg ulcers and are the final stage of the disease secondary to venous hypertension or valve insufficiency. Conventional treatment that focuses on its etiological factors continues to be the gold standard; however, 30% of ulcers do not heal with this treatment; thus, it has been seen that the use of growth factor can be used as an adjuvant for this pathology. A literature review was carried out to evaluate the evidence from systematic reviews, meta-analyses, case studies, and quantitative studies that respond to the objective of this analysis review in the different databases with specific inclusion criteria with publications between 2002 and 2022, initially finding the topical application of the factor and later, more recently, the intralesional and perilesional application, the latter being an alternative treatment for this type of pathology and generating some recommendations for using the Factor.

Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study).

BACKGROUND: Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease, with long healing time and a high recurrence rate. It imposes a heavy burden on patients, their families, and the health care system. Chronic inflammation triggered by sustained venous hypertension is now recognized as the hallmark of chronic venous disease. The anti-inflammatory effect of pentoxifylline may offer a promising avenue to treat VLUs. However, current evidence of pentoxifylline for VLUs is relatively small and of low quality. The aim of this study is to evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. METHODS: This is a randomized, double-blinded, double-dummy, multi-center, placebo-controlled clinical trial. A total of 240 patients will be randomized to receive pentoxifylline (400 mg, twice daily) or placebo for 24 weeks. All participants will receive diosmin treatment and standard care of VLUs and other comorbidities. The primary outcome is the difference in the wound healing rate within 12 weeks between pentoxifylline and placebo. Secondary outcomes include (1) percent wound size changes at 12 weeks, (2) the levels of TNF-α and IL-6, (3) venous clinical severity score and chronic venous insufficiency quality of life score, and (4) ulcer recurrence within 24 weeks. DISCUSSION: This study would evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. If confirmed, it wound offer another effective and safe therapeutic option for treatment of VLUs. TRIAL REGISTRATION: The trial was registered at the Chinese Clinical Trial Registry (No. ChiCTR-2100053053). Registered on 10 November, 2021, https://www.chictr.org.cn/showproj.aspx?proj=137010.

Cost-effectiveness of two reduced pressure compression systems in treating newly diagnosed venous leg ulcers.

OBJECTIVE: To assess the clinical outcomes and cost-effectiveness of using two different reduced pressure compression systems in treating newly diagnosed venous leg ulcers (VLUs) in clinical practice, from the perspective of the UK's National Health Service (NHS). METHODS: This was a modelling study based on a retrospective cohort analysis of the case records of patients with a newly diagnosed VLU, randomly extracted from The Health Improvement Network (THIN) database, who were initially treated with a two-layer cohesive compression bandage (TLCCB Lite; Coban 2 Lite, 3M, US) or a two-layer compression system (TLCS Reduced; Ktwo Reduced, Urgo, France). No significant differences were detected between the groups. Nevertheless, analysis of covariance (ANCOVA) was performed to enable differences in patients' outcomes between the groups to be adjusted for any heterogeneity in baseline covariates. Clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over 12 months after starting treatment. RESULTS: Time from wound onset to starting compression was a mean of two months. The probability of healing at 12 months was 0.59 in the TLCCB Lite group and 0.53 in the TLCS Reduced group. Patients in the TLCCB Lite group experienced a marginally better health-related quality of life (HRQoL) of 0.02 quality-adjusted life years (QALYs) per patient compared to those in the TLCS Reduced group. The 12-month NHS wound management cost was £3883 per patient treated with TLCCB Lite and £4235 per patient treated with TLCS Reduced. When the analysis was repeated without ANCOVA, the findings from the base case analysis remained unchanged (i.e., use of TLCCB Lite improved outcomes at lower cost). CONCLUSION: Within the study's limitations, treating newly diagnosed VLUs with TLCCB Lite instead of TLCS Reduced potentially affords a cost-effective use of NHS-funded resources in clinical practice, since it is expected to result in an increased healing rate, better HRQoL and a lower NHS wound management cost.

Prospective study on the clinical and economic burden of venous leg ulcers in the tropics.

OBJECTIVE: Venous leg ulcers (VLUs) are both chronic and recurrent. The treatment of such ulcers often require multiple outpatient visits and dressing changes. Several reports on the costs of treating such VLUs have been reported in the west. We prospectively evaluated the clinical and economic burden of VLUs in a population of Asian patients in the tropics. METHODS: Patients from a prospective two-center study conducted at two tertiary hospitals in Singapore, as a part of the Wound Care Innovation in the Tropics program, between August 2018 and September 2021 were recruited. The patients were followed up for 12 weeks (visit 1 to visit 12), until index ulcer healing, death, or lost to follow-up (whichever came first). These patients were then followed up 12 weeks later to determine the longer term outcome of the wound (healed, recurrence, remained unhealed). The itemized costs derived from the medical service were retrieved from the relevant departments of the study sites. The patients' health-related quality of life was assessed at baseline and the last visit of the 12-week follow-up period (or until index ulcer healing), using the official Singapore version of the EuroQol five-dimension-5L questionnaire, which also includes a visual analog scale (EQ-VAS). RESULTS: A total of 116 patients were enrolled; 63% were men, and the mean patient age was 64.7 years. Of the 116 patients, 85 (73%) had a healed ulcer at 24 weeks (mean duration to ulcer healing, 49 days), and 11 (12.9%) had experienced ulcer recurrence within the study period. Within the 6-month follow-up period, the mean direct healthcare cost per patient was USD$1998. The patients with healed ulcers had significantly lower costs per patient compared with those with unhealed ulcers (USD$1713 vs USD$2780). Regarding health-related quality of life, 71% of the patients had a lower quality of life at baseline, which had improved at 12 weeks of follow-up, with only 58% of the patients reported to have a lower quality of life. Also, the patients with healed ulcers scored higher for both utilities (societal preference weights) and EQ-VAS at follow-up (P < .001). In contrast, patients with unhealed ulcers only scored higher EQ-VAS at follow-up (P = .003). CONCLUSIONS: The findings from this exploratory study provide information on the clinical, quality of life, and economic burden of VLUs in an Asian population and suggest the importance of healing VLUs to reduce the effects on patients. The present study provides data as a basis for economic evaluation as a consideration for the treatment of VLUs.

Protocolo y algoritmo de diagnóstico, tratamiento y derivación ágil de las úlceras de la extremidad inferior / Protocol and algorithm for diagnosis, treatment and early referral of lower limb ulcers

Las úlceras venosas son una patología muy prevalente, especialmente en pacientes de edad avanzada. repercutennegativamente en la calidad de vida de los pacientes y conllevan un importante consumo de recursos. este artículopropone un práctico algoritmo para el diagnóstico y el tratamiento de las úlceras en la pierna con el objetivo deoptimizar su manejo. existe una amplia literatura sobre el tema, pero sigue existiendo una brecha entre la evidenciacientífi ca y la práctica clínica que seguimos tratando de minimizar. Laboratorios Urgo propuso al Capítulo español de Flebología y Linfología la creación de un comité de expertos deespaña y portugal para la elaboración de un algoritmo de diagnóstico, tratamiento y derivación ágil de las úlcerasen la extremidad inferior. Se realizó una búsqueda bibliográfica sistemática y se tuvieron en cuenta las guías depráctica clínica (GpC). Se diseñó un algoritmo sobre una regla nemotécnica alfabética que busca ayudar a memorizar los pasos clave deldiagnóstico y del tratamiento de estas úlceras. Se englobaron todos los aspectos prácticos, desde la valoración en atención primaria por médicos y enfermerashasta la atención especializada por el especialista en angiología y cirugía vascular. Con las letras del abecedario dela a hasta la F, resumimos los pasos necesarios para asegurar el diagnóstico de la úlcera, el mejor (best) tratamientolocal, terapia compresiva, tratamiento preventivo de recidiva después de la cicatrización de la úlcera y estrategiaquirúrgica y farmacológica.el diagnóstico preciso, la actuación correcta ajustada a las GpC y la derivación temprana para valorar estrategiasquirúrgicas o escleroterapia contribuyen a la resolución y a la reducción del tiempo de cicatrización de las úlcerasy la mejora de la calidad de vida de los pacientes. Seguir las GpC a través de un algoritmo reduce el consumo derecursos y de gasto, acelerando la cicatrización de la úlcera y previniendo su recidiva.(AU)

Venous ulcers are a prevalent disease, especially in elderly patients. they have a negative impact in patients’ qualityof life and carry a significant economic burden. this article suggests an algorithm for the diagnosis and treatment oflower extremity ulcers in order to optimize their management. there is huge evidence and multiple organizationshave published guidelines, consensus documents and treatment recommendations. nevertheless, there is still agap between evidence and clinical practice. Urgo Laboratories proposed the Spanish phlebology and Lymphology Chapter the creation of a Spanish andportuguese experts committee the elaboration of an algorithm for diagnosis and treatment and early referral oflower extremity ulcers. a systematic review was performed, considering the current clinical practice guidelines. the algorithm was designed on a simple alphabetic mnemonic rule aiming to easily memorize the key points andmost relevant issues of the diagnosis and treatment of these ulcers.all necessary steps from primary care nurses and physicians to Vascular Surgery were considered. With the alphabetletters from a to F in Spanish, all key points were summed up. to confirm ulcer diagnosis (asegurar el diagnóstico dela úlcera), best local treatment, compressive therapy, preventive treatment after healing (tratamiento preventivo derecidiva después de la cicatrización de la úlcera), surgical strategy (estrategia quirúrgica) and pharmacological strategy(estrategia farmacológica).an accurate diagnosis, a clinical practice according to the clinical practice guidelines and an early referral to thespecialist in order to determine if there is a surgical or interventional strategy are essential to effective resolutionand reduction of ulcer healing time, and finally to prevent its recurrence.(AU)

Relative cost-effectiveness of three compression bandages in treating newly diagnosed venous leg ulcers in the UK.

OBJECTIVE: To assess the clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2, 3M, US) compared with a two-layer compression system (TLCS; KTwo, Urgo, France) and a cohesive inelastic bandage system (CIBR; Actico, L&R, Germany) in treating newly diagnosed venous leg ulcers (VLUs) in clinical practice, from the perspective of the UK's National Health Service (NHS). METHOD: This was a modelling study based on a retrospective cohort analysis of the case records of patients with a newly diagnosed VLU randomly extracted from the The Health Improvement Network (THIN) database who were treated with TLCCB, TLCS or CIBR. No significant differences were detected between the groups. Nevertheless, analysis of covariance was performed to enable differences in patients' outcomes between the groups to be adjusted for any heterogeneity in baseline covariates. Clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over 12 months after starting treatment. RESULTS: There were 250 patients in each group. Time from wound onset to starting compression was a mean of two months. The healing distribution of the TLCCB-treated patients was significantly different from that of the other two cohorts (p=0.003); the probability of healing at 12 months was 0.62, 0.51 and 0.49 in the TLCCB, TLCS and CIBR groups, respectively. Patients treated with TLCCB experienced better health-related quality of life (HRQoL) over 12 months (0.86 quality-adjusted life years (QALYs) per patient), compared with those treated with TLCS and CIBR (0.83 and 0.82 QALYs per patient, respectively). The 12-month NHS wound management cost was £3693, £4451 and £4399 per patient in the TLCCB, TLCS and CIBR groups, respectively. CONCLUSION: Within the model's limitations, treating newly diagnosed VLUs with TLCCB instead of the other two compression systems appears to afford a more cost-effective use of NHS-funded resources in clinical practice, since it is expected to result in increased healing, better HRQoL and a lower wound management cost for the NHS.

Effect of four-layer dressing on the microbiological profile of venous leg ulcer.

OBJECTIVE: Venous leg ulcer (VLU) is a chronic disease and has periods of exacerbation and remission. Various bandage systems-single-layered, double-layered and multiple-layered with elastic and non-elastic components-have been developed. The requirement for sustained pressure brought about the introduction of the four-layer bandage. We studied the bacteriology of VLUs and the effect of four-layer bandages on their healing. METHOD: Clinical details of all patients, with wound size measurement by gauze piece, wax paper and scale, were recorded. The wounds were initially debrided and photographic records of all patients were maintained. Patients were followed up every week, when the dressings and four-layer bandages were changed. RESULTS: A total of 60 patients were recruited to the study with four patients having bilateral disease and so a total of 64 VLUs were evaluated. Of these, 60 (93.8%) healed completely, one (1.6%) healed partially and three (4.7%) did not heal. After excluding the four VLUs that did not fully heal, 10 (16.7%) had recurrence while 50 (83.3%) had no recurrence in the follow-up period, which lasted for one year. During the first visit (baseline), meticillin-resistant Staphylococcus aureus (MRSA) was isolated in 29 (45.31%) VLUs and Pseudomonas spp. in 20 (31.25%) VLUs. With subsequent dressing, the VLU size decreased and the culture of the VLU was sterile from the third culture onwards in 45 cases. There was a significant correlation (p<0.001) between VLU size and the number of dressings. CONCLUSION: Compression therapy is the mainstay of treatment of VLU, with rapid healing and improvement in bacteriological profile. Compression in the range of 30-40mmHg is the most effective treatment for uncomplicated VLUs with adequate arterial competency.

Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom.

BACKGROUND: Wounds cost £8.3 billion per year in the United Kingdom (UK) annually. Venous leg ulcers (VLUs) account for 15% of wounds and can be complicated to heal, increasing nurse visits and resource costs. Recent wound bed preparation consensus recommends wound cleansing and biofilm disrupting agents. However, inert cleansers such as tap water or saline are inexpensive, an evaluation of evidence is required to justify the higher upfront costs of treatment with active cleansers. We undertook a cost-effectiveness analysis of the use of a biofilm disrupting and cleansing solution and gel, Prontosan® Solution and Gel X, (PSGX) (B Braun Medical), as compared to the standard practice of using saline solution, for treating VLUs. METHODS: A Markov model was parameterised to one-year costs and health-related quality of life consequences of treating chronic VLUs with PSGX versus saline solution. Costs are viewed from a UK healthcare payer perspective, include routine care and management of complications. A systematic literature search was performed to inform the clinical parameters of the economic model. Deterministic univariate sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were undertaken. RESULTS: For PSGX an Incremental Net Monetary Benefit (INMB) of £1,129.65 to £1,042.39 per patient (with a Maximum Willingness to Pay of £30k and £20k per QALY respectively), of which cost savings are £867.87 and 0.0087 quality-adjusted life years (QALYs) gain per patient. PSA indicates a 99.3% probability of PSGX being cost-effective over saline. CONCLUSIONS: PSGX for the treatment of VLUs is dominant compared with saline solution in the UK with expected cost-savings within a year and improved patient outcomes.

The co-design of an exercise-based, lifestyle intervention for people with venous leg ulcers; a self-care, expert-supported strategy for a chronic condition.

Exercise is recommended as an adjunct treatment, alongside compression therapy to increase venous leg ulcer (VLU) wound healing times, however, there are no published programmes available that support patients to exercise at home on their own. To develop an exercise-based lifestyle intervention that is feasible and acceptable to people with VLUs, a participatory approach was utilised. Clinicians, researchers, and people living with VLUs collaborated in the design of "FISCU Home". Two focus groups and nine interviews were conducted with people living with a VLU. Tissue viability nurses provided clinical expertise. Data was analysed through thematic analysis. Ten key themes were identified and incorporated into FISCU Home: (I) a condition-specific flexible programme, (II) personal assessment and tailored exercises, (III) tapered individualised support, (IV) short lower-intensity sessions, (V) chair-based options, (VI) falls prevention, (VII) accessible resources, (VIII) functional, compact, self-managed exercises, (IX) a behaviour change strategy, and (X) education. FISCU Home has integrated patients' needs and preferences with evidence-based principles and theory to create an exercise-based lifestyle intervention for people with VLUs. FISCU Home could provide a mainstream adjunct therapy in wound care and support the movement towards self-management.