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Biofilms are a key driver of chronicity and treatment failure in diabetic foot ulcers (DFUs), yet clinical evidence quantifying their impact and management remains fragmented. This systematic narrative review synthesised recent evidence (2015–2025) on the prevalence, diagnostics, and management of biofilm in DFUs. A Systematic Review of the Literature (SRL) was conducted following PRISMA 2020 guidelines across PubMed/MEDLINE, Scopus, Cochrane Library and ScienceDirect. Eligible studies included adults with DFUs reporting biofilm/bioburden metrics or interventions aimed at biofilm disruption. Risk of bias was assessed using RoB 2 for randomised trials and ROBINS-I for non-randomised studies. Data were narratively synthesised by evidence tier (Tier 1 = clinical; Tier 2 = preclinical/mechanistic). Of 600 records screened, 25 studies met inclusion criteria (Tier 1 n = 9; Tier 2 n = 5; reviews n = 11). Over half of bacterial isolates in DFUs were biofilm producers, with multidrug resistance exceeding 90% in several cohorts. Fungi were detected in 31% of ulcers by qPCR but only 9% by culture. Tier 1 clinical evidence supports standard care components—debridement, antiseptics, and negative-pressure wound therapy—for improved healing, though direct antibiofilm outcomes remain limited. Emerging strategies (enzymatic agents, peptides, cold plasma, smart dressings) show promise in vitro but lack clinical translation. Evidence for direct antibiofilm efficacy in DFUs remains scarce. Current data justify maintaining guideline-based care while prioritising trials that integrate validated biofilm endpoints, standardised microbiological methods, and antifungal components. Distinguishing established from experimental approaches is essential to advancing safe, evidence-based biofilm management in DFUs.
Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).
This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.
The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.
by Shirley Ge, Hope Lappen, Luz Mercado, Kaylee Lamarche, Theodore J. Iwashyna, Catherine L. Hough, Virginia W. Chang, Adolfo Cuevas, Thomas S. Valley, Mari Armstrong-Hough
BackgroundRacial and ethnic disparities in the delivery and outcomes of critical care are well documented. However, interventions to mitigate these disparities are less well understood. We sought to review the current state of evidence for interventions to promote equity in critical care processes and patient outcomes.
MethodsFour bibliographic databases (MEDLINE/PubMed, Web of Science Core Collection, CINAHL, and Embase) and a list of core journals, conference abstracts, and clinical trial registries were queried with a pre-specified search strategy. We analyzed the content of interventions by categorizing each as single- or multi-component, extracting each intervention component during review, and grouping intervention components according to strategy to identify common approaches.
ResultsThe search strategy yielded 11,509 studies. Seven-thousand seventeen duplicate studies were removed, leaving 4,491 studies for title and abstract screening. After screening, 93 studies were included for full-text review. After full-text review by two independent reviewers, eleven studies met eligibility criteria. We identified ten distinct intervention components under five broad categories: education, communication, standardization, restructuring, and outreach. Most examined effectiveness using pre-post or other non-randomized designs.
ConclusionsDespite widespread recognition of disparities in critical care outcomes, few interventions have been evaluated to address disparities in the ICU. Many studies did not describe the rationale or targeted disparity mechanism for their intervention design. There is a need for randomized, controlled evaluations of interventions that target demonstrated mechanisms for disparities to promote equity in critical care.
Diabetic foot ulcers (DFUs) are a major cause of infection, hospitalisation, and amputation. Collagen-based dressings—especially collagen combined with oxidised regenerated cellulose (ORC)—are proposed to improve healing by modulating matrix metalloproteinases (MMPs), stabilising the extracellular matrix (ECM), and tempering inflammation; some formulations also include antimicrobial or bioactive adjuncts. We conducted a systematic review of randomised controlled trials (RCTs) following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance. Adults with DFUs were eligible. Interventions included collagen-alone or collagen-combination dressings (e.g., collagen–oxidised regenerated cellulose [collagen–ORC]/silver, collagen–chitosan) versus standard of care (SOC) or alternative dressings. To ensure comparable outcomes, the quantitative synthesis was pre-specified and restricted to complete wound closure (yes/no, intention-to-treat [ITT]) from collagen-combination RCTs with aligned constructs; other outcomes were synthesised narratively. Meta-analyses were performed in Microsoft Excel using Mantel–Haenszel methods for risk ratios (RR) with a fixed-effect primary model and DerSimonian–Laird random-effects sensitivity analysis; heterogeneity was summarised with Cochran's Q, between-study variance (τ 2), and Higgins' I 2 statistic (I 2), and a 95% prediction interval was reported for random-effects. (Protocol not registered). Six studies (five randomized controlled trials and one single-blinded non-randomized comparative study; total n = 314) met inclusion. In a focused meta-analysis of the two collagen-combination RCTs, treatment was associated with a higher probability of complete wound closure versus control (RR 1.69, 95% confidence interval [CI] 1.05–2.72; I 2 = 0%). One assessor-blinded RCT of collagen alone reported higher 12-week closure versus a placebo dressing and was not pooled due to heterogeneity. Across studies, signals also favored collagen-based care for earlier area reduction and, in one trial, fewer infection-related withdrawals; mechanistic work showed reductions in MMP-9/TIMP-2. However, most trials were small and single-centre, comparators and adjuncts varied, follow-up was short (~8 days–24 weeks, clinical endpoints typically 4–20 weeks), outcome definitions were non-standardised, and key confounders (off-loading, infection management, vascular status, glycaemic control) were inconsistently addressed. Collagen-based dressings—particularly collagen-combination formulations—appear to improve complete closure when added to the standard of care (SOC) for diabetic foot ulcers (DFUs), but the evidence is limited by study size, heterogeneity, and risk of bias. Larger, prospectively registered, multicentre RCTs with standardised outcomes and longer follow-up are needed to define clinical and cost-effectiveness and to identify which patients benefit most. Collagen–ORC dressings show promise as an adjunctive treatment for DFUs by influencing the inflammatory microenvironment and supporting tissue repair. However, the certainty of the current evidence remains limited, highlighting the need for further high-quality randomised studies.
The aims of this study were (1) To investigate the availability of NHS funded in vitro fertilisation (IVF) treatment for individuals affected by Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) from all Integrated Care Boards (ICBs) across England and (2) To assess the ethical implications of piecemeal funding for those with MRKH.
This was a mixed-methods study containing both quantitative and qualitative data. We filed freedom of information (FOI) act requests on 01/06/2023 for all 42 ICBs across England via secure email.
The study focused on England.
All 42 ICBs across England were contacted.
The FOI requests asked for information concerning the provision of funded IVF for uterine factor infertility, and if this included individuals with MRKH. Where assistance was available, we recorded what it comprised along the IVF cycle. If IVF was not offered, we recorded the rationale provided by the ICB.
Responses were received from all 42 ICBs across England. Seven stated that they would fund IVF and cryopreservation of embryos to women with MRKH and other absolute uterine factor infertility diagnoses (NHS Humber and North Yorkshire, NHS Dorset, NHS Devon, NHS Cornwall and Isles of Scilly, NHS Buckinghamshire, Oxford and Berkshire, NHS South Yorkshire and NHS West Yorkshire). However, the number of cycles, the length of cryopreservation and whether they would fund embryo transfer into a surrogate differed between ICBs.
Of the remainder, three (NHS Leicester, Leicestershire and Rutland, NHS Greater Manchester and NHS Hampshire and Isle of Wight) described some provision of fertility preservation (cryopreservation of oocytes or embryos) for women with uterine factor infertility, two of whom suggested their policy may include women with MRKH (NHS Greater Manchester and NHS Hampshire and Isle of Wight). Two ICBs (NHS Gloucester and NHS Bedford, Luton and Milton Keynes) explained that individual funding applications would be considered when made by clinicians on the patient’s behalf, but no information was provided on how many times requests had been made and granted. The remaining 30 ICBs explained that no part of a surrogacy pregnancy would be funded, owing to concerns around commercial surrogacy, which is illegal in the UK.
This work has revealed that only a small proportion of ICBs (7/42, 17%) treat women with MRKH like any other woman applying for NHS fertility treatment. The study revealed that decisions by ICBs not to fund IVF treatments based on concerns about commercial surrogacy create significant inequities. It unfairly penalises individuals with MRKH who require surrogacy as part of their fertility treatment. These individuals face a unique set of reproductive challenges, and denying them access to NHS-funded IVF treatments exacerbates existing inequalities. Furthermore, if individuals with MRKH accept that the expenses of the surrogate will be met by them rather than the ICB, it is unjustifiable to deny them the IVF component of the treatment if they meet all the other criteria for eligibility. Moreover, the fact that some ICBs do fund IVF for individuals with MRKH indicates that legal concerns regarding surrogacy are unfounded and inconsistently applied. This discrepancy highlights the need for a standardised approach that ensures equitable access to fertility treatments across all regions.
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.
Background
Up to 45% of patients report cancer-related cognitive impairment (CRCI). A variety of characteristics are associated with the occurrence and/or severity of CRCI. However, an important gap in knowledge of risk factors for CRCI is the relative contribution of each factor. The multifactorial model of cancer-related cognitive impairment (MMCRCI) is a conceptual model of CRCI that can be used to evaluate the strength of relationships between various factors and CRCI.
Objectives
The purpose of this study was to use structural regression methods to evaluate the MMCRCI using data from a large sample of outpatients receiving chemotherapy (n = 1,343). Specifically, the relationships between self-reported CRCI and four MMCRCI concepts (i.e., social determinants of health, patient-specific factors, treatment factors, and co-occurring symptoms) were examined. The goals were to determine how well the four concepts predicted CRCI and determine the relative contribution of each concept to deficits in perceived cognitive function.
Methods
This study is part of a larger, longitudinal study that evaluated the symptom experience of oncology outpatients receiving chemotherapy. Adult patients were diagnosed with breast, gastrointestinal, gynecological, or lung cancer; had received chemotherapy within the preceding 4 weeks; were scheduled to receive at least two additional cycles of chemotherapy; were able to read, write, and understand English; and gave written informed consent. Self-reported CRCI was assessed using the attentional function index. Available study data were used to define the latent variables.
Results
On average, patients were 57 years of age, college educated, and with a mean Karnofsky Performance Status score of 80. Of the four concepts evaluated, whereas co-occurring symptoms explained the largest amount of variance in CRCI, treatment factors explained the smallest amount of variance. A simultaneous structural regression model that estimated the joint effect of the four exogenous latent variables on the CRCI latent variable was not significant.
Discussion
These findings suggest that testing individual components of the MMCRCI may provide useful information on the relationships among various risk factors, as well as refinements of the model. In terms of risk factors for CRCI, co-occurring symptoms may be more significant than treatment factors, patient-specific factors, and/or social determinants of health in patients receiving chemotherapy. 
FreshRSS 