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A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
Wound care remains a high-priority area for improvement in the Canadian health care system. Older adults aged 65 and older are disproportionately affected by chronic and non-healing wounds and often experience multiple co-morbid conditions, challenges which can be further complicated by living in rural and northern areas. A workshop-based multi-methods study was conducted to describe rural and northern perspectives on opportunities and feasibility to implement innovative wound care technologies. Each workshop included pre- and post- workshop surveys, a live demonstration of Swift Skin and Wound, a Q&A session, and facilitated discussion exploring the technology's feasibility, usability, and accessibility in northern and rural care contexts. Participants who volunteered for the study included care staff and healthcare executives (N = 11), described their perspectives on implementing AI-driven digital wound care management solutions with a focus on integration into health care settings. Three themes were identified including: confidence and optimism in improving wound care management, recognition of the superiority of AI-driven digital wound care solutions over current practices, and the importance of adaptable change processes for successful adoption. While generalizability may be limited, findings suggest that adopting AI-driven wound care tools could improve wound assessment accuracy and streamline care for aging populations in rural and northern areas.
Renal disease, including chronic kidney disease (CKD) and end-stage renal disease (ESRD), has a profound impact on wound healing. Multiple studies have demonstrated that renal disease leads to an increased risk of diabetic foot ulcers, the formation of unique wounds like calciphylaxis, slower wound healing and a higher risk of amputation. This review details the interrelated mechanisms by which renal disease impacts wound healing. Motor and sensory neuropathies contribute to wound formation via foot deformities and decreased sensation. Neuropathies also decrease neuropeptide release, impairing angiogenesis and inflammatory regulation. Accumulation of uremic toxins in renal disease leads to vessel wall calcification, impairing blood supply and predisposing patients to calciphylaxis. Vitamin and mineral deficiencies lead to impaired clotting, development of a chronic inflammatory state and decreased collagen production. Renal disease and its comorbidities are also associated with immune dysregulation, increasing the risk of wound infections and promoting the persistence of pro-inflammatory macrophages. While hypoxia-inducible factor-1α (HIF-1α) promotes angiogenesis under hypoxic conditions in normal wound healing, oxidative stress and chronic hypoxia in renal disease generate an environment that compromises the activity of HIF-1α. Inadequate erythropoietin response to hypoxia also leads to anaemia, further impairing oxygen delivery to wound sites. Clinically, these factors result in increased 10-year mortality for patients with DFU and CKD compared to those with DFU alone, both with and without amputation. We must utilise our understanding of the pathophysiology of impaired wound healing in renal disease to target preventative measures, optimise treatment and improve overall outcomes.
Negative pressure wound therapy is currently one of the most popular treatment approaches that provide a series of benefits to facilitate healing, including increased local blood perfusion with reduced localized oedema and control of wound exudate. The porous foam dressing is a critical element in the application of this therapy and its choice is based on its ability to manage exudate. Industry standards often employ aqueous solutions devoid of proteins to assess dressing performance. However, such standardized tests fail to capture the intricate dynamics of real wounds, oversimplifying the evaluation process. This study aims to evaluate the technical characteristics of two different commercial polyurethane foam dressings during negative pressure wound therapy. We introduce an innovative experimental model designed to evaluate the effects of this therapy on foam dressings in the presence of viscous exudates. Our findings reveal a proportional increase in dressing fibre occupancy as pressure intensifies, leading to a reduction in dressing pore size. The tests underscore the pressure system's diminished efficacy in fluid extraction with increasing fluid viscosity. Our discussion points to the need of establishing standardized guidelines for foam dressing selection based on pore size and the necessity of incorporating real biological exudates into industrial standards.
As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
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