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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]

Abstract Background Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC) available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively. The extracellular matrix (ECM) in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair. To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. Methods/Design To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts) and SOC plus Oasis® (ECM devoid of living cells) in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. Discussion If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test our hypothesis. Trial registration ClinicalTrials.gov: NCT01450943. Registered: 7 October 2011

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.)

Competing Interests: Conflicts of interest Dr Lev-Tov is a consultant for AbbVie, Inc, Cosmo Pharmaceuticals, Inc, Next Science, Inc, Novartis, Inc, and Pfizer, Inc.

Significance: Wounds of all types remain one of the most important, expensive, and common medical problems, for example, up to approximately two-thirds of the work time of community nurses is spent on wound management. Many wounds are treated by means of dressings. The materials used in a dressing, their microarchitecture, and how they are composed and constructed form the basis for the laboratory and clinical performances of any advanced dressing. Recent Advances: The established structure/function principle in material science is reviewed and analyzed in this article in the context of wound dressings. This principle states that the microstructure determines the physical, mechanical, and fluid transport and handling properties, all of which are critically important for, and relevant to the, adequate performances of wound dressings. Critical Issues: According to the above principle, once the clinical requirements for wound care and management are defined for a given wound type and etiology, it should be theoretically possible to translate clinically relevant characteristics of dressings into physical test designs resulting specific metrics of materials, mechanical, and fluid transport and handling properties, all of which should be determined to meet the clinical objectives and be measurable through standardized bench testing. Future Directions: This multidisciplinary review article, written by an International Wound Dressing Technology Expert Panel, discusses the translation of clinical wound care and management into effective, basic engineering standard testing requirements from wound dressings with respect to material types, microarchitecture, and properties, to achieve the desirable performance in supporting healing and improving the quality of life of patients.

Objective: The objective of this study is to characterize breath-hold (BH)-induced oxygenation changes in diabetic foot ulcers (DFUs) and develop an oxygenation flow index (OFI) to discern nonhealing from healing DFUs. Approach: The imaging approach utilizes an innovative BH stimulus that induces vasoconstriction and measures for altering oxygenation flow in and around the tissues of DFUs and controls. The modified Beer-Lambert law was utilized to calculate hemoglobin-based spatiotemporal oxygenation maps in terms of oxygen saturation. Results: We found controls had synchronous BH-induced oxygenation changes across the dorsal (OFI: 29.0%) and plantar (OFI: 57.6%) aspects of the foot. Nonhealing DFUs, however, had less synchronous BH-induced oxygenation changes (OFI <28%). In addition, two complicated healing DFU cases, or cases with underlying issues or poor long-term healing outcomes, were observed to have OFIs <28%. Innovation: An OFI was developed to differentiate nonhealing DFUs from healing DFUs using a single, noncontact, near-infrared optical scanner for spatiotemporal oxygenation monitoring. The OFI has potential to provide immediate feedback on the microcirculation in DFUs, through hemoglobin-based oxygenation parameters. Conclusion: A preliminary threshold (OFI <28%) could differentiate nonhealing and complicated DFUs from healing DFUs. The overall oxygenation flow pattern was less synchronous (or the OFI value reduced) in the nonwound areas of the feet that were nonhealing. In other words, the reduced OFI value (<28%) in the entire foot, excluding the wound region is a possible indicator that the wound may not heal.

Competing Interests: Conflicts of interest Dr Alavi serves in the board of HSF, as investigator for BI and Processa and consultant 23 for AbbVie, BI, InflaRx, Novartis, UCB. Dr Lev-Tov is the founder, own stock and have a podcast for 24 Learnskin.com; consults for Abbvie Inc, Next Science Inc, Novartis Inc, Pfizer Inc; is a clinical trialist 25 for Incyte Inc, Medline Inc, Molnlyke Inc, Moonlake Inc, Novartis Inc, Sigvaris Inc, Solascure Inc, 26 Tissue Tech Inc, UCB Inc; and recieves research grant support for Essity Inc, Next Science Inc, 27 Sigvaris Inc, Vomaris Inc. Drs Chopra, Anand, Authors Brito, Coutts, Drs George, Kimball, and Kirsner have no conflicts of interest to declare.

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.)