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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., (© 2024 SolasCure Ltd. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

This article describes the contemporary bioengineering theory and practice of evaluating the fluid handling performance of foam-based dressings, with focus on the important and clinically relevant engineering structure-function relationships and on advanced laboratory testing methods for pre-clinical quantitative assessments of this common type of wound dressings. The effects of key wound dressing material-related and treatment-related physical factors on the absorbency and overall fluid handling of foam-based dressings are thoroughly and quantitively analysed. Discussions include exudate viscosity and temperature, action of mechanical forces and the dressing microstructure and associated interactions. Based on this comprehensive review, we propose a newly developed testing method, experimental metrics and clinical benchmarks that are clinically relevant and can set the standard for robust fluid handling performance evaluations. The purpose of this evaluative framework is to translate the physical characteristics and performance determinants of a foam dressing into achievable best clinical outcomes. These guiding principles are key to distinguishing desirable properties of a dressing that contribute to optimal performance in clinical settings., (© 2024 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

The aim of this article is to identify and describe clinical practice performance characteristics for bordered foam dressings in the treatment of complex wounds. Our recently published systematic review of outcomes and applied measurement instruments for the use of bordered foam dressings in complex wounds has led to us identifying a range of important clinical and patient-centred issues related to this dressing class. Specifically, here, we focus on an overview of performance criteria in the areas of application, adhesion, exudate management and debridement functions of bordered foam dressings. Our hope is that by highlighting the clinical performance criteria, future testing standards for wound dressings will more closely match our clinical expectations and, thereby, assist clinicians to make better wound treatment choices based on meaningful and clinically relevant dressing product performance standards. complex wounds, complex wound care, treatment, bordered foam dressings, dressing performance., (© 2023 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

In the treatment of acute and chronic wounds, the clinical performance of a given foam-based dressing, and, ultimately, the wound healing and cost of care outcomes are strongly influenced by the mechanical performance of the foam material/s within that dressing. Most aspects of the mechanical performance of foam materials, for example, their stiffness, frictional properties, conformability, swelling characteristics and durability, and the overall mechanical protection provided by a foam-based dressing to a wound strongly depend on the microstructure of the foam components, particularly on their microtopography, density and porosity. This article, therefore, provides, for the first time, a comprehensive, self-inclusive compilation of clinically relevant theoretical and practical considerations, based on published analytical and experimental research as well as clinical experience related to the mechanical performance of foams in foam-based wound dressings. The current bioengineering information is useful for establishing understanding of the importance of mechanical properties of foams in foam-based dressings among clinicians and researchers in industry and academia, and other potential stakeholders in the wound care field, for example, regulators and buyers. This information is also particularly important for the development of standardised test methods for the evaluation of foam-based wound dressings and resulting standard mechanical performance metrics for these dressings., (© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

Competing Interests: Declaration of competing interest None.

Objective: The aim of this review article was to identify reported outcomes and measurement instruments used in clinical research on bordered foam dressings in the treatment of complex wounds., Methods: MEDLINE (PubMed interface), Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, and The Cochrane Library were systematically searched using a combination of key terms including; wounds, bordered foam dressing, and treatment. Studies were included if they (1) targeted an adult population, (2) addressed the treatment of complex wounds with a bordered foam dressing as the primary wound dressing, (3) were retrieved from original research, and (4) were published between 2000 and 2022. There were no restrictions on language or study design. Studies that focused primarily on the prevention of complex wounds were excluded. Data extraction included outcome domains, outcomes, instruments, time points, and outcome measures. The OMERACT Filter 2.0 was used as a conceptual framework for the extraction of outcomes., Results: A total of 24 outcome domains and 82 outcomes were identified. The outcomes were categorised into five core areas: (1) impact on life, (2) dressing performance, (3) pathophysiological manifestations, (4) resource use, and (5) adverse events. Thirtynine outcomes (47.0%) were measured at more than one time point. The most frequently reported time point was 'at the end of treatment' (62.7%). Outcomes were measured using self-report instruments, clinical observations, and bio-physiological instruments., Conclusion: This systematic review identified reported outcomes and measurement instruments in research on bordered foam dressings in the treatment of complex wounds. The variety and lack of consistency in terms of instruments, time points and outcome measurements made it difficult to compare data directly across different reported studies. A solution to the variety in outcome reporting across studies in complex wound care, and moreover for the treatment with bordered foam dressings, is the development of a Core Outcome Set (COS). The outcomes in this review article will inform the next steps of developing a COS, where patients, clinicians and researchers will be involved to decide on the final outcomes included in a COS for the treatment of complex wounds with bordered foam dressings., (Copyright © 2022 Tissue Viability Society / Society of Tissue Viability. Published by Elsevier Ltd. All rights reserved.)

Impaired wound healing associated with recurrent Staphylococcus aureus infection and unresolved inflammation are hallmarks of nonhealing diabetic foot ulcers (DFUs). Perforin-2, an innate immunity molecule against intracellular bacteria, limits cutaneous infection and dissemination of S. aureus in mice. Here, we report the intracellular accumulation of S. aureus in the epidermis of DFUs with no clinical signs of infection due to marked suppression of perforin-2. S. aureus residing within the epidermis of DFUs triggers AIM2 inflammasome activation and pyroptosis. These findings were corroborated in mice lacking perforin-2. The effects of pyroptosis on DFU clinical outcomes were further elucidated in a 4-week longitudinal clinical study in patients with DFUs receiving standard care. Increased AIM2 inflammasome and ASC-pyroptosome coupled with induction of IL-1β were found in nonhealing DFUs compared with healing DFUs. Our findings revealed that perforin-2 suppression, intracellular S. aureus accumulation, and associated induction of pyroptosis contribute to healing inhibition and prolonged inflammation in patients with DFUs.

The increasing legalization of Cannabis for recreational and medicinal purposes in the United States has spurred renewed interest in the therapeutic potential of cannabinoids (CBs) for human disease. The skin has its own endocannabinoid system (eCS) which is a key regulator of various homeostatic processes, including those necessary for normal physiologic wound healing. Data on the use of CBs for wound healing are scarce. Compelling pre-clinical evidence supporting the therapeutic potential of CBs to improve wound healing by modulating key molecular pathways is herein reviewed. These findings merit further exploration in basic science, translational and clinical studies., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Wounds that exhibit delayed healing have a tremendous impact on health care expenditures and place patients at serious risk for severe complications including death. The healing of a chronic wound requires the restoration of multiple factors that normally work in concert to repair the damaged skin barrier. Skin substitutes have shown great promise for use as adjunctive therapies for refractory wounds by providing cells, soluble mediators, and extracellular matrix materials needed to stimulate healing. There are a growing variety of skin substitutes available on the market with many indications, and appropriate selection can impact healing outcomes. Skin substitutes can be broadly divided into cellular and acellular devices, yet within these categories, each product has its own unique composition and mechanism for promoting healing. Here we summarize the characteristics and indications of cellular and acellular matrices commonly used in wound care with the most evidence supported by randomized control trials and prospective studies. This review aims to provide dermatologists and other wound care clinicians with a helpful guide on how to approach skin substitutes, from preparing the wound bed for application, to making the proper selection for patients' individual wounds.

J Drugs Dermatol. 2018;17(1):57-64.

Nanoformulation of curcumin may be the key to unlocking its wound healing potential., (Copyright © 2017, American Association for the Advancement of Science.)

Background: Diabetic foot ulcers (DFUs) are extremely debilitating and difficult to treat. Multidisciplinary management, patient education, glucose control, debridement, offloading, infection control, and adequate perfusion are the mainstays of standard care endorsed by most practice guidelines. Adjunctive therapies represent new treatment modalities endorsed in recent years, though many lack significant high-powered studies to support their use as standard of care., Objective: This update intends to identify recent, exclusively high level, evidence-based evaluations of DFU therapies. Furthermore, it suggests a direction for future research., Methods: PubMed, Embase, Ovid Technologies, CINAHL, Cochrane, and Web of Science databases were systematically searched for recent systematic reviews published after 2004, and randomized controlled trials published in 2012-2013 that evaluated treatment modalities for DFUs. These papers are reviewed and the quality of available evidence is discussed., Results: A total of 34 studies met inclusion criteria. Studied therapies include debridement, off-loading, negative pressure therapy, dressings, topical therapies, hyperbaric oxygen therapy, growth factors, bioengineered skin substitutes, electrophysical therapy, and alternative therapy. Good-quality evidence is lacking to justify the use of many of these therapies, with the exception of standard care (offloading, debridement) and possibly negative pressure wound therapy., Limitations: There is an overall lack of high-level evidence in new adjunctive management of DFU. Comparison of different treatment modalities is difficult, since existing studies are not standardized., Conclusions: Many therapeutic modalities are available to treat DFU. Quality high-level evidence exists for standard care such as off-loading. Evidence for adjunctive therapies such as negative pressure wound therapy, skin substitutes, and platelet-derived growth factor can help guide adjunctive care but limitations exist in terms of evidence quality.

Dear Editor, Venous leg ulcers (VLUs) are painful and recalcitrant to therapy and represent a significant burden on patients' quality of life and society.[1] Therefore, innovative therapies are needed. GLO:F03/01may20:bjd18743-fig-0001.jpg PHOTO (COLOR): (a-c) Patient 1, with a right anterior leg ulcer, (a) before starting topical valsartan application, (b) 2 months after treatment and (c) 3 months after treatment. In diabetic aged mice and diabetic pigs, topical valsartan 1% gel significantly accelerated wound healing by selective blockage of AT1.[2] It has been suggested that systemic AT1 receptor blockers impair fibroblast migration and delay wound healing.[7] Therefore, topical treatment is a promising therapy, especially in patients receiving oral valsartan for their hypertension. [Extracted from the article]