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.

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.

Treatment of bacterially contaminated lower extremity ulcers with a fatty acid-containing wound matrix: a case series.

OBJECTIVE: The aim was to evaluate the effectiveness of a marine omega fatty acid-containing multimodal wound matrix (MWM) in reducing bacterial contamination and supporting wound area reduction (WAR) in patients with hard-to-heal wounds of varying aetiologies. METHOD: A prospective, single-site, pilot case series of patients with hard-to-heal wounds. All wounds were considered non-healing prior to inclusion as they had failed to achieve at least 50% WAR after at least four weeks of standard of care (SoC) treatments. Patients were seen once weekly for wound assessments, matrix application and dressing changes. Baseline and weekly fluorescence images, standard wound images and wound measurements were obtained. RESULTS: A total of three patients, two with venous leg ulcers (VLUs) and one with a diabetic foot ulcer (DFU) were enrolled in this pilot study. The mean baseline wound age prior to study enrolment was 24 weeks, with a mean baseline wound size of 8.61cm2. The two VLUs went on to complete closure. The DFU displayed a total WAR of 53% by six weeks, when the patient was lost to follow-up due to a geographical relocation. The mean percentage area reduction of all wounds combined was 82% upon study completion. CONCLUSION: The use of MWM proved to be effective and safe in this patient cohort. The wounds included in this case series failed to enter a healing trajectory with SoC wound therapies. The MWM supported wound closure and reduced bacterial loads in this patient cohort.

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

Use of amniotic membrane in hard-to-heal wounds: a multicentre retrospective study.

OBJECTIVE: Hard-to-heal (chronic) wounds negatively impact patients and are a source of significant strain on the healthcare system and economy. These wounds are often resistant to standard of care (SoC) wound healing approaches due to a diversity of underlying pathologies. Cellular, acellular, and matrix-like products, such as amniotic membranes (AM), are a potential solution to these challenges. A growing body of evidence suggests that AM may be useful for treatment-resistant wounds; however, limited information is available regarding the efficacy of dehydrated amniotic membrane (DHAM) on multi-aetiology, hard-to-heal wounds. Therefore, we analysed the efficacy of DHAM treatment in reducing the size of hard-to-heal diabetic and venous leg ulcers (VLUs) that had failed to improve after SoC-based treatments. METHOD: In this multicentre retrospective study, we analysed wound size during clinic visits for patients being treated for either diabetic or VLUs. During each visit, the treatment consisted of debridement followed by application of DHAM. Each wound was measured after debridement and prior to DHAM application, and wound volumes over time or number of DHAM applications were compared. RESULTS: A total of 18 wounds in 11 patients were analysed as part of this study. Wounds showed a significant reduction in volume after a single DHAM application, and a 50% reduction in wound size was observed after approximately two DHAM applications. These findings are consistent with reports investigating DHAM treatment of diabetic ulcers that were not necessarily resistant to treatment. CONCLUSION: To our knowledge, this study is the first to directly compare the efficacy of standalone DHAM application to hard-to-heal diabetic and venous leg ulcers, and our findings indicate that DHAM is an effective intervention for resolving these types of wounds. This suggests that implementing this approach could lead to fewer clinic visits, cost savings and improved patient quality of life. DECLARATION OF INTEREST: This research was supported in part by Merakris Therapeutics, US, and facilitated access to deidentified patient datasets, which may represent a perceived conflict of interest; however, the primary data analysis was performed by FSB who is unaffiliated with Merakris Therapeutics. TCB is a founder, employee of and shareholder in Merakris Therapeutics; WSF is a co-founder of, consultant for, and shareholder in Merakris Therapeutics, and was also supported by the National Institutes of Health National Center for Advancing Translational Sciences Clinical and Translational Science Awards Grant KL2 Scholars Program (KL2TR001441). The research was also supported through endowments to WSF from the University of Texas Medical Branch Mimmie and Hallie Smith Endowed Chair of Transplant Research and the John L Hern University Chair in Transplant Surgery.

Experiences of patients living with venous leg ulcers: A qualitative meta-synthesis.

BACKGROUND: Venous Leg Ulcer is characterized by a prolonged course, delayed healing and high recurrence rate. Bringing challenges to patient treatment and care.Patients need to control the negative behavioral factors that affect wound healing and recurrence, which seriously affect their quality of life. OBJECTIVE: To integrate qualitative research related to the disease experience and feelings of patients with Venous Leg Ulcer and provide references for optimizing patient intervention measures. METHODS: We searched databases including Pubmed, CINAHL, EMBASE, Web of Science, PsycINFO, The Cochrane library, ProQuest, CNKI and Wan Fang Data from 2000 to February 2023 to collect qualitative studies on the experiences of patients living with venous leg ulcers. We used the Australian JBI evidence-based healthcare center qualitative research quality evaluation standard to evaluate the quality of literature. After quality assessment, meta-synthesis was used to summarize and explain the results. RESULTS: Sixteen studies were eligible for inclusion, and the total number of included individuals was 146. The perceptions of individuals with Venous Leg Ulcer synthesized three overarching themes and their subthemes: disease cognition (Understanding the cause of VLU,Understanding of VLU treatment, Recognition of VLU recurrence); physical experience (Pain symptoms, Other symptoms); and psychological and social experience (psychological impact, health education, economic burden, social relations, response strategies, doctor-patient/nurse-patient relationship). CONCLUSION: The lives of patients with venous leg ulcers are influenced by various complex and diverse factors. Healthcare professionals must recognize the patient's emotional needs, establish a multidimensional support system, and promote wound healing through patient self-adjustment.

Investigating low rates of compliance to graduated compression therapy for chronic venous insufficiency: A systematic review.

Chronic venous insufficiency (CVI) is a chronic lower limb progressive disorder with significant burden. Graduated compression therapy is the gold-standard treatment, but its underutilisation, as indicated in recent literature, may be contributing to the growing burden of CVI. The aim of this systematic review is to determine the reasons for poor compliance in patients who are prescribed graduated compression therapy in the management of chronic venous insufficiency. A systematic review of the literature was conducted to identify the reasons for non-compliance in wearing graduated compression therapy in the management of chronic venous insufficiency. The keyword search was conducted through Medline, PubMed, CINAHL, Cochrane library, AMED, and Embase databases from 2000 to April 2023. Qualitative and quantitative studies were included with no study design or language limits imposed on the search. The study populations were restricted to adults aged over 18 years, diagnosed with chronic venous insufficiency. Of the 856 studies found, 80 full-text articles were reviewed, with 14 being eligible for the review. Due to the variability in study designs, the results were summarised rather than subjected to meta-analysis. There are five main overarching themes for non-compliance, which are physical limitations, health literacy, discomfort, financial issues, and psychosocial issues with emerging sub-themes. Graduated compression therapy has the potential to reduce the burden of chronic venous insufficiency if patients are more compliant with their prescription.

Managing venous leg ulceration: variance and variety.

Frameworks of care have been developed to enhance and standardise care for those with venous leg ulcers. Community nurses are faced with an array of frameworks and guidance documents on which to base their care. This article outlines and discusses variations in the information provided within the body of evidence relating to the care of venous leg ulcers. It is based on the findings of ongoing study for a PhD thesis.

Consistency of wound care in Leg Clubs.

Mr B had lost his wife of 65 years and was distraught, but he tried to move on with life. However, while playing football he injured his leg, which then developed into a venous ulcer that was to last for many years. Unfortunately, his care was inconsistent, and the wound was not progressing. He found the local Leg Club and decided to self-refer. He not only went on to achieve wound closure rapidly, but he found a social atmosphere in the club, made friends and learned how to prevent the wound from recurring. He felt that consistency of care was the reason for the rapid progress.

A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease.

BACKGROUND: Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. METHODS: We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. RESULTS: Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, ß = -0.27 (95% CI: -2.55 to 1.85), recurrence, ß = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, ß = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. CONCLUSION: This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. CLINICAL IMPACT: Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

Knowledge assessment among subjects with chronic venous leg ulcer in outpatient setting: Translation and adaptation of a tool to identify subjects at risk of poor understanding.

Promotion of self-care is an important issue in the treatment of chronic diseases such as venous leg ulcers, as adequate self-care can prevent complications and ulcer recurrence. However, only a few tools have been developed and tested to assess the knowledge of patients with venous leg ulcers. This study aimed to translate, adapt and validate in an Italian language and context a questionnaire to assess the knowledge of patients with venous leg ulcers about their disease (pathophysiology, risk factors, lifestyle changes due to ulcer) and the proper management of the ulcer to prevent recurrence. This is a cross-sectional study divided into two phases: (1) translation and cross-cultural adaptation of the 'Educational Interventions in Venous Leg Ulcer Patients' tool in a six-stage process and (2) validation and reliability study with patients with active ulceration. There was great agreement for the English-to-Italian translation. In content validation, the tool showed good applicability among experts. Adjustments were made to improve semantic equivalence, and the questionnaire was made to be easy and quick to administer. The results of the target population showed a low level of knowledge among the patients. Knowing the deficiencies of the patients makes it possible to create educational projects to improve their abilities. Now more than ever, it is necessary to improve self-care and patient knowledge, allowing home care, improving autonomy, and avoiding hospital care that results in higher costs and risks. This questionnaire could be used in future studies to identify topics that need to be reinforced through education and to improve the awareness and self-care of these patients.

Iliac vein recanalisation and stenting accelerate healing of venous leg ulcers associated with severe venous outflow obstruction.

Obstruction involving the iliac veins and/or inferior vena cava is highly comorbid in patients with chronic venous leg ulcers and is a barrier to healing. Intervention with venous stenting is recommended to promote wound healing; however, there is limited data to quantify the effects of venous outflow restoration on wound healing. We retrospectively identified patients with venous ulcers and comorbid venous outflow obstruction. Data regarding demographics, wound size, degree of obstruction, interventions, wound healing and recurrence were collected. Intervention was performed when possible and patients were grouped based on whether or not the venous outflow was reopened successfully and maintained for at least 1 year. Outcomes, including time to wound healing, wound recurrence, stent patency and ulcer-free time, were measured. Patients who maintained a patent venous outflow tract experienced higher rates of wound healing (79.3%) compared to those with persistent outflow obstruction (22.6%) at 12 months (p < 0.001). Ulcer-free time for the first year was also greater with patent venous outflow (7.6 ± 4.4 months versus 1.8 ± 3.0 months, p < 0.0025). Patients with severe obstruction of the venous outflow tract experience poor healing of VLUs despite appropriate wound care. Healing time is improved and ulcer-free time increased after venous intervention with stenting to eliminate obstruction.

Barriers and facilitators to use of compression therapy by people with venous leg ulcers: A qualitative exploration.

AIMS: To explore barriers to, and facilitators of, adherence to compression therapy, from the perspective of people with venous leg ulcers. DESIGN: An interpretive, qualitative, descriptive study involving interviews with patients. METHODS: Participants were purposively sampled from respondents to a survey exploring attitudes to compression therapy in people with venous leg ulcers. Sampling continued until data saturation: 25 interviews between December 2019 and July 2020. Inductive thematic analysis of interview transcripts was undertaken to create a framework for the data, followed by deductive analysis informed by the Common-Sense Model of Self-Regulation. RESULTS: A range of knowledge and understanding about the cause of venous leg ulcers and the mechanisms of compression therapy was demonstrated, which was not particularly related to adherence. Participants talked about their experience with different compression methods and their concerns about the length of time healing could take. They also spoke about aspects of the organization of services which affected their care. CONCLUSION: Identifying specific, individual barriers/facilitators to compression therapy is not simple, rather factors combine to make adherence more or less likely or possible. There was no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; different compression therapies presented different challenges for patients; unintentional non-adherence was frequently mentioned; and the organization of services could impact on adherence. Ways in which people could be supported to adhere to compression therapy are indicated. Implications for practice include issues relating to communication with patients; taking into account patients' lifestyles and ensuring that they know about useful 'aids'; providing services that are accessible and provide continuity of appropriately trained staff; minimizing unintentional non-adherence; and acknowledging that healthcare professionals will always need to support/advise those who cannot tolerate compression. IMPACT: Compression therapy is a cost-effective, evidence-based treatment for venous leg ulcers. However, there is evidence that patients do not always adhere to this therapy and there is limited research investigating reasons why patients do not wear compression. The study found no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; that different compression therapies presented different challenges for patients; that unintentional non-adherence was frequently mentioned and that the organization of services could impact on adherence. Attending to these findings offers the opportunity to increase the proportion of people undergoing appropriate compression therapy and achieving complete wound healing, the main outcome desired by this group. PATIENT/PUBLIC CONTRIBUTION: A patient representative sits on the Study Steering Group, contributing to the work from developing the study protocol and interview schedule to interpretation and discussion of findings. Members of a Wounds Research Patient and Public Involvement Forum were consulted about interview questions.

International validation of a venous leg ulcer risk assessment tool.

OBJECTIVE: To internationally validate a tool for predicting the risk of delayed healing of venous leg ulcers (VLUs). METHOD: A 10-item tool including sociodemographic factors, venous history, ulcer and lower limb characteristics, compression and mobility items to determine the risk of delayed healing of VLUs has previously been developed and validated in Australia. This study prospectively validated this tool using receiver operating characteristic (ROC) methods; using the area under the curve (AUC) to quantify the discriminatory capability of the tool to analyse the international populations of the UK, Austria and New Zealand. RESULTS: The validation of the tool in the UK, Austria and New Zealand has indicated that the model has moderate discrimination and goodness-of-fit with an AUC of 0.74 (95% CI: 0.66-0.82) for the total risk assessment score. CONCLUSION: The international validation of a risk assessment tool for delayed healing of VLUs will allow clinicians globally to be able to determine realistic outcomes from an early assessment and to be able to guide early tailored interventions to address the specific modifiable risk factors and thus promote timely healing.

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.

Quality of life of patients with venous leg ulcers treated by a one-stop clinic.

OBJECTIVE: Venous leg ulcers (VLU's) can impair patient quality of life (QoL) and have a significant impact on healthcare costs. Symptoms include pain and pruritis but can also lead to low self-esteem and sleep deprivation, which are often underestimated by physicians. METHOD: We introduced a system in which patients with a VLU were examined and treated via a one-stop clinic. In this exploratory study, we evaluated the experiences of patients in this new setting using the Skindex-29 and conducting semi-structured interviews. RESULTS: A total of seven patients completed the questionnaires and interviews. The study found that younger patients had an impaired QoL due to symptoms disrupting activities of daily living. The cooperation between healthcare workers, the consistent execution of the treatment plan by different care providers and the close contact between staff and patients were appreciated by patients. Patients were positive about the continuous care provided by homecare workers at the patient's home, and experienced higher levels of attention to their illness. CONCLUSION: The introduction of a one-stop clinic led to better insight and awareness among staff of patients' symptoms and complaints. More focus and time should be given to patient-oriented symptoms, which was highly appreciated by patients in this study. This could eventually lead to a reduction in the impairing effects of VLUs on patients' lives and healthcare costs due to fewer visits to the hospital.

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.

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.

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.