Conectar
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.
This study aimed to compare the 3-year recurrence rates of diabetic foot ulcers (DFU) and the rate of endovascular reintervention for chronic limb-threatening ischaemia (CLTI) to recurrence rates of advanced-stage cancers. We systematically collected original data reporting 3-year DFU recurrence from studies published through 2024 and calculated a pooled mean. These findings were compared to recurrence rates for advanced breast, prostate, colorectal, and lung cancers using contemporary sources from the National Cancer Institute and American Cancer Society. CLTI reintervention data were drawn from the BEST-CLI trial. The pooled 3-year DFU recurrence rate was 58%, while the CLTI reintervention rate was 50%—comparable to cancer recurrence rates: breast (25%–40%), prostate (30%–40%), colorectal (30%–50%), and lung (60%–80%). Despite these comparable risks, DFU and CLTI remain underrecognized in terms of their recurrent burden on individuals, families, and health systems. The data presented here underscore the need to reframe healed DFU and post-intervention CLTI not as an endpoint but as a remission—a state requiring structured surveillance and proactive management, much like in oncology. Developing interdisciplinary survivorship care plans for individuals with DFU and CLTI, modelled on those used in cancer care, may improve communication, enhance secondary prevention, and foster more ulcer-free, hospital-free, and activity-rich days.
The classification of wound care products as form-stable dressings remains challenging due to the lack of objective and quantitative, material-science-based criteria. This study introduces a rheological testing framework to determine form stability of wound dressing materials. Using dynamic, oscillatory shear rheology, we evaluated the viscoelastic properties and responses of two tube-dispensed model dressings and compared them to those of honey, a high-viscosity liquid used in wound ointments. Measurements of the material storage modulus, loss modulus and phase angle demonstrated that both model dressings exhibit predominantly solid-like responses, confirming their classification as form-stable wound dressings despite being applied from a tube. The notably low phase angles of these dressings indicate structural integrity, which is essential for the mechanical protection of wounds; honey exhibited a liquid response and a high phase angle, without structural integrity. The reported laboratory method and findings support the implementation of rheological classification as a standardised, objective and quantitative approach for wound care product categorisation, independent of the packaging or application mode. Importantly, this study establishes a foundation for a material-science-driven classification framework, with implications for informed clinical decision-making and reimbursement policies.
This initiative utilised knowledge translation (KT) strategies, including digital storytelling (DST) as both a narrative and educational tool, to amplify voices and support trauma-informed healing for individuals living with chronic wounds. A multi-method KT approach was employed, involving: (1) patient DST; (2) a national Patient Journey conference; (3) webinars and conference sessions; (4) a social media campaign; (5) infographics and supplements and (6) an open-access digital library. Since its launch in November 2021, the initiative has garnered significant engagement. Twenty-five patients and care partners across Canada shared their wound care journeys. In June 2022, 191 patients, advocates, policymakers and healthcare providers attended the inaugural virtual Patient Journey. Additionally, 102 participants joined three Patient Journey events between June and October 2024. Patient stories received 23 012 views, and the social media campaign and infographics reached over 900 healthcare professionals, policymakers and advocates across Canada. The initiative raised awareness of the challenges faced by individuals living with wounds. Storytellers described grief, frustration and confusion, underscoring the need for person-centred wound care, timely specialised services and better healthcare navigation. Their experiences revealed care gaps, highlighting the urgent need for systemic change to promote equity and inclusivity in wound care.
Diabetes related foot ulcers (DFUs) are complex and costly to manage, with the prevalence of non-healing wounds steadily increasing across the globe. Non-healing wounds can occur when clinicians fail to undertake an appropriate assessment, fail to recognise the importance of systemic or local complications, or provide the optimal treatment. The aetiological causes behind non-healing wounds are multifactorial; however, the purpose of this article is to focus on the role of oxygen in non-healing wounds and to introduce readers to advances in the delivery of topical oxygen therapy (TOT) via a haemoglobin spray. Importantly, this article incorporates a clinical decision support tool (CDST) to help clinicians identify the most appropriate individuals for whom topical haemoglobin may be most beneficial and the most appropriate time for introducing the intervention to improve wound healing outcomes.
Through a prospective comparative intention-to-treat study, we studied the impact of remote monitoring of chronic wounds on safety and on the consumption of healthcare system resources. From January to June 2023, 103 consecutive patients were managed according to conventional follow-up (group CF, 61 patients) or to follow-up in which remote wound monitoring (group RM, 42 patients) could be used. Data were collected prospectively. Statistical analysis was performed on an intention-to-treat basis, analysing data on treatment safety (mortality, major amputation, wound healing, use of emergency services), clinical results (closure and time to closure of the wound) organisational effectiveness (consultation, hospitalisation, use of unscheduled care), and estimated cost. The use of telemonitoring did not alter the safety criteria for the management of chronic wounds. It allowed a 35 days reduction of the time to wound-closure (p = 0.05). It led to a 55% reduction in hospital consultations (p ≤ 0.01). These factors have resulted in an estimated reduction in the cost of care of 1666 euros. The constated reduction in unscheduled care (visit of emergency services, emergency hospitalisation) was not significant. Remote monitoring of chronic wounds is safe, and clinically efficient (reduced healing time), compared to conventional monitoring. It decreases the need for in-hospital consultations and the overall cost of the treatment and thus may ease the access to specialised care in wound healing.
In preclinical studies, topical oxygen treatment (TOT) was shown to enhance wound healing by applying supplemental oxygen topically to the surface of a moist wound at normobaric conditions. The objective of this systematic review and meta-analysis is to provide a thorough evaluation of published RCTs and observational studies that compare supplemental TOT with standard wound care. A total of 1077 studies were obtained from a variety of databases, including PubMed, ScienceDirect, Web of Science, ProQuest, Scopus, ClinicalTrials.gov, EU Clinical Trial Registers, and Preprints.org. The Jadad scale was employed to assess the reliability of RCT studies, while the Newcastle-Ottawa Scale (NOS) was employed to assess the quality of observational studies. Seven RCT studies (n = 692) and two controlled observational studies (n = 111) were analysed. The rate of healed wounds was 25.8% in the control group and 43.25% in the adjuvant TOT group, which shows the use of TOT significantly increased the number of healed wounds (RR = 1.77; 95% CI 1.18–2.64; p = 0.005). A significant decrease in the percentage of wound area was found in the TOT group in RCT studies (mean difference = 15.64; 95% CI 5.22–26.06; p = 0.003). In observational studies, the rate of healed wounds was 37.5% in the standard care group and 80.95% in the adjuvant TOT group, which shows a significant increase in the number of healed wounds in the adjuvant TOT group (RR = 2.15; 95% CI 1.46–3.15; p < 0.00001). Topical oxygen therapy is considered a great adjuvant therapy for chronic wound healing, particularly wounds with vascular compromise such as diabetic ulcers and pressure ulcers. Further studies on this topic are still needed as there are a lot of potential uses for this technology in various types of wounds.
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.
This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).
Preserved allogeneic donor skin still represents one of the gold standard therapies in temporary wound coverage in severely burned patients or chronic wounds. Allogeneic skin grafts are currently commercially available as cryo- or glycerol-preserved allografts through skin tissue banks all over the world. Most of the skin tissue banks rely on human cadaveric skin donations. Due to the chronic shortage of human allogeneic transplants, such as skin, and increasing costs in the procurement of allografts from other skin tissue banks, Hannover Medical School has been building up its own skin tissue bank based on allogeneic skin grafts from living donors who underwent surgical treatment (i.e., body-contouring procedures, such as abdominioplasties). This article presents procedures and protocols for the procurement and processing of allogeneic skin grafts according to national legislation and European regulations and guidelines. Beside protocols, initial microbiological data regarding the sterility of the harvested grafts are presented. The results currently form the basis for further investigations as well as clinical applications. In summary, a microbiological testing and acceptance procedure is presented that ensures adequate patient safety and skin viability.
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.
The aim was to analyse changes in the perceived quality of life of patients with an ostomy during the first year after surgery at two or three follow-ups. This is a prospective study of a cohort of 55 patients who were ostomised between June 2021 and September 2022 and cared for under the recommendations set out in the Registered Nurses' Association of Ontario® best practice guideline Supporting Adults Who Anticipate or Live with an Ostomy as part of the Best Practice Spotlight Organisation® (BPSO®) programme. The Stoma Quality of Life tool was used. A univariate analysis was performed to identify variables associated with a non-improvement in quality of life. Variables showing p < 0.1 were included in a multivariate model. Patients with an ostomy exhibited a moderate-to-good perception of quality of life in both the personal and social dimensions, with no worsening over the first year. Being female (OR = 10.32) and being younger (OR = 0.89) were associated with a higher risk of no improvement in quality of life. The most frequent complications were urinary leakage (p = 0.027) and dermatitis (p = 0.052) at first follow-up; and parastomal hernia (p = 0.009) and prolapse (p = 0.05) at third follow-up. However, they did not lead to a worsening of quality of life, suggesting that these patients were adequately supported under the BPSO® programme.
The inaugural expert consensus and guidance for Nutrition Interventions in Adults with Diabetic Foot Ulcers (DFU) have been welcomed by clinicians internationally. This short report aimed to determine how the macronutrient and micronutrient status of individuals living with DFU compared to the American Limb Preservation Society Nutrition Interventions in Adults with DFU expert consensus and guidance. Descriptive analysis was conducted as a secondary analysis of an existing dataset. Mean (SD) dietary intake, the proportion meeting the nutrition recommendations and the proportion exceeding the upper limit (UL) for specific vitamins and minerals were reported. Most individuals with DFU do not meet current consensus guidelines for optimal dietary intake for wound healing, with inadequacies evident for fibre, zinc, protein, vitamin E and vitamin A. Future iterations of the consensus guideline should consider using evidence-informed recommendations for clinical practice, with the inclusion of all nutrients that are essential for wound healing in DFU.
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