Is Shock Wave Application Effective on Various Chronic Wounds in the Geriatric Population? Preliminary Clinical Study.

Purpose: Extracorporeal shock wave therapy (ESWT) is a beneficial adjunct modality for chronic wounds. Limited research has been conducted on pressure ulcers (PUs), while the majority of studies have focused on diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This study aimed to evaluate the short-term effects of radial ESWT in older adults with chronic wounds. Patients and Methods: This study involved a total of 31 wounds: PUs (n=22), VLUs (n=7), and DFUs (n=2). A single radial ESWT was performed with 300 + 100 shocks per cm2, pressure of 2.5 bar, energy of 0.15 mJ/mm2, and frequency of 5 Hz. Assessments using digital planimetry and clinical methods, utilizing the Wound Bed Score (WBS) and the Bates-Jansen Wound Assessment Tool (BWAT) were performed before the radial ESWT application (M0) and one week after (M1). Results: A significant wound decrease in planimetry was noted (pre-ESWT vs post-ESWT), with wound area from 9.4 cm2 to 6.2 cm2, length from 6.4 cm to 3.9 cm, and width from 2.8 cm to 2.1 cm (p<0.001). Additionally, a substantial clinical improvement was noted in both the WBS with a 31.25% increase and the BWAT with a 20.00% increase (p<0.001). It was also found a significant correlation between the planimetric and clinical outcomes for both tools: WBS (r=-0.446, p=0.012) and BWAT (r=0.327, p=0.073). Conclusion: The ESWT application yields substantial immediate clinical effects that support the healing of chronic wounds in older adults. Even a single ESWT session can prove to be clinically effective and beneficial in the management of chronic wounds.

Efficacy and safety of an anti-infection topical desiccating agent (DEBRICHEM) in hard-to-heal wounds.

A single centre, non-comparative evaluation was undertaken to observe the clinical results achieved when following best practice for the application of Debrichem. The treatment protocol involved use of this debridement product plus standard of care. The sample comprised 21 patients with complex, non-healing wounds of various aetiologies. One patient dropped out of the evaluation for unknown reasons. Wound types were either venous leg ulcers (n=16) or post-traumatic wounds (n=25). The mean wound duration was 22 months (range: 2 weeks-17 years). Over the 4-week follow-up period, there was a decline in the mean percentage of devitalised tissue present on the wounds, reducing from 69% at baseline to 49% at week 4. Most of the devitalised tissue was slough, for which the mean baseline percentage was 63% compared with an endpoint of 49%. Conversely, the mean percentage of granulation tissue increased from 31% at baseline to 51% at week 4. The mean visual analogue pain score reported during application was 4/10, where 0 represents no pain. However, general wound-related pain scores improved during the follow-up period, with no scores above 2 at week 2, compared with five at baseline. The results indicate that Debrichem is a safe and effective method of debridement that requires minimal training and is single use.

NR1I2 as a core biological target in chronic venous ulcer tissues treated with ultrasound therapy.

Ultrasound therapy is a method of applying ultrasonic energy to the stimulation produced by human body to change the function and tissue state of the body in order to achieve the purpose of treating diseases. Chronic venous ulcer is a common chronic skin ulcer. GSE222503 for ultrasound therapy of chronic venous ulcers was downloaded from gene expression omnibus database, which were used to identify differentially expressed genes. Weighted gene co-expression network analysis, functional enrichment analysis, gene set enrichment analysis, immune infiltration analysis and construction and analysis of protein-protein interaction network were performed. Draw gene expression heatmaps. Comparative toxicogenomics database analysis was performed. Two hundred thirty-five differentially expressed genes were obtained. According to gene ontology analysis, in biological process analysis, they were mainly enriched in positive regulation of cellular biosynthetic process, reproductive cell development, vasculogenesis, vascular morphogenesis, and inflammatory response. In cellular component analysis, they were mainly enriched in leading edge of growing cell, extracellular matrix binding organelle, F-actin capping protein complex. In molecular function analysis, they were mainly concentrated in receptor ligand activity, cytokine receptor binding. In Kyoto encyclopedia of genes and genomes analysis, they were mainly enriched in cytokine-cytokine receptor interaction, PI3K-Akt signaling pathway, HIF-1 signaling pathway, heme biosynthesis. In weighted gene co-expression network analysis, the soft threshold power was set to 9. Thirty modules were generated. PF4, NR1I2, TTC16, H3C12, KLRB1, CYP21A2 identified by 4 algorithms (MCC, EPC, closeness, stress). Heatmap of core gene expression showed that H3C12, KLRB1, PF4, NR1I2 were all underexpressed in samples of ultrasound-treated chronic venous ulcers and overexpressed in samples of untreated chronic venous ulcers. Comparative toxicogenomics database analysis showed that H3C12, KLRB1, PF4, NR1I2 are associated with thrombophlebitis, phlebitis, vascular malformations, metabolic syndrome, ulcers, and inflammation. In samples of chronic venous ulcer tissue treated with ultrasound, NR1I2 shows low expression, while in samples of chronic venous ulcer tissue without ultrasound treatment, it shows high expression. This finding suggests a potential role of NR1I2 in the process of ultrasound therapy for chronic venous ulcers, which may be related to the therapeutic effect of ultrasound therapy on chronic venous ulcers.

Timolol in the treatment of hard-to-heal wounds: a comprehensive review.

OBJECTIVE: The aims of this study were to ascertain the effectiveness and safety of the off-label use of topical timolol as an adjunct treatment for hard-to-heal (chronic) wounds. Furthermore, to review and analyse the existing literature regarding the use of topical timolol on wounds of varying aetiologies. METHOD: A systematic review of literature in the English language published between May 1961-May 2021 on the application of topical timolol for hard-to-heal wounds in adults was performed. Each research study was evaluated by two reviewers independently. Studies eligible for inclusion in the review were randomised controlled trials (RCTs), clinical trials, observational studies of at least 4 weeks' duration, case series and case studies. Search strategies were performed according to PRISMA guidelines and included MeSH terms and keyword searches. RESULTS: An initial 878 articles were identified from a search of PubMed, Ovid Medline, Embase, Cochrane, and SCOPUS. Of these, 699 were reviewed for eligibility, 19 were read in full-text, and 12 were selected for inclusion in the review. In total, two RCTs and 10 observational studies, including five case studies, were analysed. All studies demonstrated efficacy and safety of topical timolol; however, statistical analysis remained limited by lack of blinding and small sample sizes. CONCLUSION: This review concludes with all currently available evidence that topical timolol may be considered as an effective and safe adjunct treatment for refractory wounds, primarily venous leg ulcers and diabetic foot ulcers. Given the overall safety, low cost and ease of application of topical timolol, this review provides evidence in favour of off-label use and should prompt further, more rigorous studies.

Effects of electromagnetic therapy in treating patients with venous leg ulcers: An overview of systematic reviews.

This study aims to evaluate the effects of electromagnetic therapy (EMT) on the treatment of venous leg ulcers (VLUs) by synthesising and appraising available meta-analyses (MAs) and systematic reviews (SRs). A comprehensive literature search was conducted across major databases up to 10 January 2024, focusing on SRs/MAs that investigated the use of EMT for VLUs. Selection criteria followed the PICO framework, and dual-author extraction was used for accuracy. Quality assessment tools included AMSTAR2, ROBIS, PRISMA, and GRADE. The search yielded five eligible studies. The reviews collectively presented moderate methodological quality and a low risk of bias in several domains. Reporting quality was high, albeit with inconsistencies in fulfilling certain PRISMA checklist items. The evidence quality, primarily downgraded due to small sample sizes, was rated as moderate. Whilst some studies suggest potential benefits of EMT in the treatment of VLUs, the overall evidence is inconclusive due to methodological limitations and limited sample sizes. This review underscores the need for future research with more rigorous methodologies and larger cohorts to provide clearer insights into the efficacy of EMT for VLUs.

The Mediating Role of Self-efficacy and Coping Mode Between Powerlessness and Quality of Life in Patients with Venous Leg Ulcers.

OBJECTIVE: To explore the mediating effect of self-efficacy and coping mode between powerlessness and quality of life in patients with a venous leg ulcer (VLU). METHODS: The authors used a convenience sampling method to select 208 patients with a VLU in four tertiary grade A hospitals in Qingdao and Tianjin from June 2021 to August 2022. Instruments included the Powerlessness Assessment Tool, Venous Leg Ulcer Self-efficacy Tool, Medical Coping Modes Questionnaire, and Venous Leg Ulcer Quality of Life Questionnaire. The authors used descriptive statistics, Pearson correlation, and PROCESS macros for data analysis. RESULTS: The powerlessness score was significantly negatively associated with self-efficacy and confrontation coping mode scores and positively associated with patients' quality-of-life scores. In addition, self-efficacy and confrontation coping modes separately and sequentially mediated the relationship between powerlessness and quality of life. CONCLUSIONS: Self-efficacy and confrontation coping mode play important mediating roles between powerlessness and quality of life in patients with VLUs. By decreasing patients' sense of powerlessness, boosting their self-efficacy, and encouraging them to adopt confrontation coping mode, health professionals can improve patients' quality of life.

Novel foam dressing with through holes and negative pressure wound therapy with instillation and dwell time: a retrospective cohort study.

BACKGROUND: NPWTi-d of a topical wound solution has been shown to benefit healing in a variety of wound types. This therapy has traditionally been applied via a standard ROCF-V. In 2017, a new ROCF-CC was introduced at the practice of the authors of the current manuscript for adjunctive management of patients with wounds with thick exudate and/or nonviable tissue and in cases in which surgical debridement is not available or not appropriate. OBJECTIVE: To compare the efficacy of NPWTi-d with ROCF-CC dressing (treatment) vs NPWTi-d with ROCF-V dressing (control). MATERIALS AND METHODS: An observational retrospective cohort study of hospital records of patients with VLUs treated with NPWTi-d who received ROCF-CC dressings (n = 11) vs standard ROCF-V dressings (n = 11) was conducted. NPWTi-d was chosen to promote wound healing in VLUs that were not fully responsive to advanced dressings and/or compression bandage. Solution dwell time was 10 minutes, followed by 2.5-hour NPWT cycles at -125 mm Hg. Dressings were changed every 72 hours. RESULTS: Overall, mean ± SD duration of therapy and hospital length of stay were shorter in the treatment group vs the control group (duration of therapy, 8.63 days ± 7.05 vs 11.72 days ± 17.41, respectively; P = .05, and length of stay, 9.9 days ± 2.98 vs 12.81 days ± 4.26, respectively; P = .08), but these differences were not statistically significant. Mean wound area reduction was greater in the treatment group than in the control group (14.63 cm2 ± 13.24 and 10.72 cm2 ± 14.06, respectively; P = .51), but this was not significant. CONCLUSION: ROCF-CC dressings were a useful tool in assisting wound bed preparation and reducing time to skin graft closure in this series of complex VLUs.

Development of a core outcome set for use in research evaluations of interventions for venous leg ulceration: International eDelphi consensus.

INTRODUCTION: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU. AIM: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment. METHOD: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry). RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting. RECOMMENDATIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

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.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study.

BACKGROUND: The optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. METHODS: We retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups-group A (with an intact GSV) and group B (with a stripped or ablated GSV)-were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. RESULTS: There were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. CONCLUSIONS: Our findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.

Comparison of the therapeutic efficacy of magneto-LED therapy and magnetostimulation applied as the adjuvant treatment of venous leg ulcers - preliminary study.

PURPOSE: Venous leg ulcers are chronic wounds that are difficult to cure. The aim of the study was to compare the therapeutic efficacy of two methods of physical medicine - magneto-LED therapy and magnetostimulation, applied as adjuvant treatment in the treatment of venous leg ulcers. METHODS: The study included 81 patients, 37 male (45.6%) and 44 female (54.3%) ones, age range between 45 and 90 years, with venous leg ulcers. The patients were assigned to two study groups: magneto-LED therapy (group 1) or magnetostimulation (group 2). In both groups, a total of 40 daily procedures were performed. Wound healing was evaluated using computerized planimetry and the pain intensity on numeric rating scale. RESULTS: After treatment, the decrease in healing rate in group 1 was statistically significantly higher in comparison to group 2 (p < 0.001), while a statistically significant reduction in the surface area of ulcers was obtained, amounting on the average from 6.34 ± 1.29 cm2 to 2.31 ± 1.25 cm2 in group 1 (p < 0.001), and from 6.52 ± 1.20 cm2 to 4.79 ± 1.17 cm2 in group 2 (p < 0.001). The percentage changes of ulcers area in group 1 (64.21 ± 17.94%) were statistically significantly greater as compared to group 2 (25.87 ± 14.07%) (p < 0.001). After treatment, the decrease in pain relief in group 1 was statistically significantly higher in comparison to group 2 (p = 0.006), while pain intensity after treatment decreased statistically significantly in both compared groups of patients (p < 0.001). CONCLUSIONS: Magneto-LED therapy and magnetostimulation caused significant reduction of surface area of the treated venous leg ulcers and pain intensity, yet magneto-LED therapy was more efficient. Both evaluated methods also significantly reduced pain intensity.

Chronic wounds are wounds, which despite ongoing treatment, do not heal within 6­8 weeks. A wound that occurs as a result of an ongoing disease process is called an ulcer. Leg ulcers are still a significant challenge for modern medicine because they are characterized by complex etiology, chronic pain and require specific diagnostic and therapeutic measures. In many cases, the inability to heal ulcers quickly is associated with social isolation, long-term suffering and deterioration of the quality of life of treated patients. In addition to standard treatment including surgery, pharmacotherapy and compression therapy, new more effective methods of ulcer therapy are still being sought. Nowadays, physical treatment methods are increasingly used as a supporting treatment the healing of chronic wounds. In the study, variable magnetic fields and low-energy light were used in the treatment of 81 patients (including 44 women and 37 men) in aged 45­90 years. All patients had chronic, non-healing of venous leg ulcers accompanied by severe pain. After completion of treatment, both groups of patients experienced a significant reduction of surface area of treated ulcers and a reduction in the intensity of pain ailments. According to our study results, the use of magnetic field and light therapy can be an important supportive treatment option in patients with venous leg ulcers.

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.

A systematic review of the impact of compression therapy on quality of life and pain among people with a venous leg ulcer.

AIM: To gain a greater understanding of how compression therapy affects quality of life, this systematic review appraised existing published studies measuring the impact of compression therapy on health quality of life (HRQoL), and pain, among people with venous leg ulcers (VLU). METHOD: Five databases were searched, and two authors extracted data and appraised the quality of selected papers using the RevMan risk of bias tool. Due to heterogeneity in the types of compression and instruments used to evaluate HRQoL, meta-analysis was not appropriate; thus, a narrative synthesis of findings was undertaken. RESULTS: Ten studies were included, 9 RCTs and one before-after study. The studies employed nine different HRQoL tools to measure the impact of a variety of compression therapy systems, with or without an additional exercise programme, versus other compression systems or usual care, and the results are mixed. With the use of the Cardiff Cardiff Wound Impact Schedule, the SF-8 and the SF-12, study authors found no differences in QoL scores between the study groups. This is similar to one study using QUALYs (Iglesias et al., 2004). Conversely, for studies using EuroQol-5D, VEINES-QOL, SF-36 and CIVIQ-20 differences in QoL scores between the study groups were noted, in favour of the study intervention groups. Two further studies using QUALYs found results that favoured a two-layer cohesive compression bandage and the TLCCB group, respectively. Results for the five studies that assessed pain are also mixed, with one study finding no difference between study groups, one finding that pain increased over the study period and three studies finding that pain reduced in the intervention groups. All studies were assessed as being at risk of bias in one or more domains. CONCLUSION: Results were varied, reflecting uncertainty in determining the impact of compression therapy on quality of life and pain among people with a venous leg ulcer. The heterogeneity of the compression systems and the measures used to evaluate HRQoL make it a challenge to interpret the overall evidence. Further studies should strive for homogeneity in design, interventions and comparators to enhance both internal and external validity.

First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers.

We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4-week treatment period.

Efficacy and safety of platelet-rich plasma in the treatment of venous ulcers: A systematic review and meta-analysis of randomized controlled trials.

Considering the substantial impact of venous ulcers on quality of life and healthcare systems, this study evaluated the efficacy and safety of platelet-rich plasma (PRP) in comparison to conventional therapy. A systematic review of four databases identified 16 randomized clinical trials, including 20 study groups. PRP significantly enhanced complete ulcer healing, exhibiting an odds ratio (OR) of 5.06 (95% confidence interval [CI]: 2.35-10.89), and increased the percentage of healed ulcer area by a mean difference of 47% (95% CI: 32%-62%). Additionally, PRP shortened the time required for complete healing by an average of 3.25 months (95% CI: -4.06 to -2.43). Although pain reduction was similar in both groups, PRP considerably decreased ulcer recurrence rates (OR = 0.16, 95% CI: 0.05-0.50) without increasing the risks of infection or irritative dermatitis. These results suggest PRP as a viable, safe alternative for venous ulcer treatment, providing significant improvements in healing outcomes.

A double-blind trial comparing an antimicrobial combination to standard care in hard-to-heal wounds.

OBJECTIVE: Excessive numbers of bacteria in hard-to-heal wounds impede wound healing. Numerous topical antiseptics have demonstrated effectiveness in benchtop studies; however, few clinical studies have demonstrated efficacy in the target population: patients with hard-to-heal wounds. This study addressed the clinical efficacy of a novel antibiofilm cleanser and gel in reducing bacterial load and improving wound outcomes. METHOD: Hard-to-heal wounds were photographed, measured and evaluated for bacterial load using fluorescence imaging weekly for four weeks. The target ulcers were randomised to be cleaned and treated with either a synergistic antibiofilm cleanser and antibiofilm gel with standard of care (AMC-AMG + SoC) or normal saline wash and an amorphous gel with standard of care (NSS-HG + SoC). RESULTS: A Chi-squared test of independence determined that the relationship between the treatment and the patient reaching 40% percentage area reduction (PAR) in four weeks was not significant (χ2(1, n=54)=0.73; p=0.39 at a significance level of 0.05); however, there was a strong trend favouring the antibiofilm cleanser and gel. A significant reduction (p<0.05) in bacterial load was observed in the antibiofilm group. CONCLUSION: This randomised controlled double-blind proof-of-concept study suggests that the performance of antibiofilm agents in vivo is comparable to that in vitro studies.

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.