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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.
To develop a concise Consensus Statement on the management of venous leg ulcers (VLUs) that incorporates existing standards and guidance on new technology, including improvement of calf muscle pump function and the utilisation of advanced wound therapies. A multidisciplinary panel of 19 wound healthcare providers from across Canada, who treat patients with VLUs, was formed. A draft document was created and four rounds of consultation and feedback were sought from the panel. The Consensus Statement was completed in June 2024 with 100% consensus on 20 sections and > 85% consensus on the remaining three sections. The key elements are—Clinical assessment and investigations; Treatment-compression to improve calf muscle pump function, and wound treatment with the principles of Wound Bed Preparation; When not healing or only suboptimal compression can be used - add treatment with muscle pump activator by continuous Neuromuscular Electrical Stimulation of the common peroneal nerve to improve calf muscle pump function; When VLUs are not healing with optimal therapy - an algorithm for the use of advanced wound therapies; and Prevention of VLU recurrence. The Consensus Statement is a concise guide for healthcare providers to use at the bedside and has been endorsed by leading nursing and homecare associations in Canada that also have physician representation.
Pyoderma gangrenosum (PG) is a rare, painful neutrophilic dermatosis characterized by rapidly progressing skin ulcers. Despite the importance of local wound care in managing PG, there is no consensus or evidence-based guidelines. This systematic review aimed to investigate local wound care strategies for PG. A comprehensive search of Embase, MEDLINE, and the Cochrane Library yielded 1213 references, from which 269 studies were included, covering 351 patients. The most reported treatment methods included sharp debridement (11%), topical corticosteroids (27%) and non-adherent dressings (12%). However, no clear correlation between these treatments and healing outcomes was found likely due to confounding factors such as varied wound sizes, superinfection and inconsistent reporting. Additionally, directed wound care regimens have not been able to show statistical significance for healing outcomes. Our study describes the current local wound care landscape and underscores a critical gap in the current literature regarding standardized treatment protocols for PG.
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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