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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.
There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.
The number of patients requiring wound care is increasing, placing a burden on healthcare institutions and clinicians. While negative pressure wound therapy (NPWT) use has become increasingly common, Middle East-specific wound care guidelines are limited. An in-person meeting was held in Dubai with 15 wound care experts to develop guidelines for NPWT and NPWT with instillation and dwell (NPWTi-d) use for the Middle East. A literature search was performed using PubMed, Science Direct and Cochrane Reviews. Prior to the meeting, panel members reviewed literature and existing guidelines on NPWT and/or NPWTi-d use. A wound management treatment algorithm was created. Patient and wound assessment at presentation and throughout the treatment plan was recommended. Primary closure was recommended for simple wounds, and NPWT use was suggested for complex wounds requiring wound bed preparation. NPWTi-d use was advised when wound cleansing is required, if the patient is unsuitable for surgical debridement, or if surgical debridement is delayed. When NPWTi-d is unavailable, panel members recommended NPWT. Panel members recommended NPWT for wound bed preparation and NPWTi-d when wound cleansing is needed. These recommendations provide general guidance for NPWT and NPWTi-d use and should be updated as more clinical evidence becomes available.
This study investigates cortical reorganisation and hemodynamic responses in individuals with lower extremity amputation and replantation using functional near-infrared spectroscopy (fNIRS). A total of 15 healthy controls, four left lower limb amputees and one replantation patient were included. Oxyhemoglobin (oxy-Hb) activations were measured during 10 unilateral lower limb motor tasks (toe, ankle, knee and hip movements). Non-parametric analyses revealed significant differences in cortical activation between amputees and controls, particularly during knee flexion and extension. Three-dimensional contrast maps demonstrated that oxy-Hb activity in amputees extended from the M1-leg area into somatosensory regions, reflecting neuroplastic remapping. In contrast, the replantation patient exhibited activation patterns closer to the control group, especially in knee and hip tasks. These findings indicate that fNIRS can sensitively capture hemispheric dynamics during unilateral lower limb movements and highlight neuroplastic adaptations following amputation and replantation. Such insights may guide future neuroprosthetic design and rehabilitation strategies.
The article describes the outcomes of a single-centre investigation on the use of OZOILE to improve the healing process in patients with chronic diabetic ulcers. This is a non-randomised interventional study which aims to assess the differences between two groups (total 200 patients) by evaluating healing time at 15, 30, 45, 60, 75 and 90 days. Pain assessment with VAS scale at 15, 30 and 45 days, biofilm test and tissue regeneration by histological evaluation were also taken into consideration. The outcomes show faster healing, reduced pain, control of local infection, aesthetically pleasing and qualitatively better healing. Our treatment strategy involves applying OZOILE detergent without rinsing, Ozoile spray oil and Ozoile cream followed by a non-adherent dressing (paraffin gauze). This integrated protocol shows a safe and effective treatment for diabetic chronic wound healing in a cost-effective manner. The group treated with the Rigenoma/Ozoile protocol demonstrated significantly superior outcomes compared to the control group, including accelerated healing, reduced pain levels, effective management of unpleasant odour, and high levels of compliance from both patients and surgeons. Overall, Ozoile markedly reduced healing time compared with standard care, with results robust across multiple analytical approaches.
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.
Hard-to-heal wounds are frequently associated with underlying conditions such as diabetes, vascular disease, and biofilm-related infections. Accurate identification of microbial origin is essential, but is often hindered by biofilms. This study evaluated whether sonication of wound dressings, combined with different sample transport methods, improves bacterial detection in venous leg ulcers. In a prospective observational case–control study, six patients with hard-to-heal venous leg ulcers received treatments with medical-grade honey (MGH) (n = 1), ceramic dressings – “Cerdak” (n = 2), or hydroactive dressings (n = 3). Three microbiological samples were collected per patient: (1) conventional wound swab (Levin's technique) in Amies medium; (2) sonicate fluid from used dressings transported in sterile tubes without medium; and (3) sonicate fluid in haemoculture tubes (BACT/ALERT). Total pathogen count and diversity were compared across sampling methods. Patient quality of life (QoL) was assessed using the Wound-QoL instrument. Sonication revealed additional pathogens not detected by conventional swabs. The highest number of pathogens was found in sonicate fluid transported in haemoculture tubes (n = 43), followed by swabs (n = 39) and sterile tube transport (n = 30). Adequate treatment significantly improved patients' QoL during the healing process. Dressing sonication, especially with haemoculture tube transport, enhances microbial identification and may improve diagnosis and management of hard-to-heal wounds.
Diabetic foot ulcers (DFUs) are severe complications of diabetes that often lead to major amputations. Despite care advancements, approximately 50% of minor amputations do not heal, resulting in major amputations and increased mortality. This study evaluated the effectiveness of adipose-derived stem cells (ASCs) obtained through superficial enhanced fluid fat injection (SEFFI) in improving healing rates after minor amputations in DFUs. It was a prospective, single-arm, observational cohort study. The patients were monitored for half a year using monthly assessments. The primary endpoint was the healing rate of the amputation stumps after minor amputations coupled with ASC injections. Secondary endpoints included safety, feasibility, adverse events and analysis of variables associated with healing including the analysis of the injected mesenchymal adipose stem cell populations. Of the 256 screened patients, 40 were enrolled. At 6 months, 55% of the treated stumps had healed completely. The median healing time was 69 days. Technical success was achieved in all cases without device-related complications. Multivariable Cox models identified haemodialysis, opioid use and the injected number of CD45-positive cells as risk factors for healing failure. CD73 expression was positively associated with healing. The SEFFIDiFA trial demonstrated a promising 69% healing probability at 6 months post-amputation. This minimally invasive approach showed a higher healing rate with fewer complications. This study supports the potential of ASCs in enhancing wound healing in DFUs and highlights the importance of CD73 expression for successful outcomes. Further research is warranted to validate these findings and optimise the technique.
This study aimed to determine if skin types can be accurately assessed via melanin scores measured with a colormeter, and whether scar characteristics of people with different skin types are different at various stages of healing. Melanin scores of a Cortex DSM Colormeter were validated against the Fitzpatrick skin type questionnaire in healthy volunteers and unaffected skin of burn and scar patients (N = 137) to determine melanin index cut-offs per skin type. Scar quality in children and adults at 3, 6, and 12 months post-burn using DSM Colormeter and the Patient and Observer Scar Assessment Scale (POSAS) was analysed in a cohort of > 1000 patients. Data from 137 individuals showed good correlation between melanin index and Fitzpatrick skin types (Spearman's rho: 0.72 Dermaspectrometer, 0.69 DSM II; p < 0.0001). Scar characteristics varied by skin type for erythema, pigmentation, vascularization, and overall POSAS scores. Children had significantly thicker scars than adults, regardless of skin type, varying from 0.3 to 1.4 points difference on the observer scale at 12 months post burn. We conclude that skin type can be objectively classified using the melanin index, showing a strong correlation with the Fitzpatrick questionnaire. Skin type influences scar outcomes, especially pigmentation and vascularization. Children, particularly those with lighter skin, tend to develop thicker scars than adults. Recognising these differences can improve scar management and patient education.
The healthcare landscape in South Africa is challenging with a complex patient population and a stressed healthcare system. Negative pressure therapy-based systems such as negative pressure wound therapy with instillation and dwell (NPWTi-d) and closed incision negative pressure therapy (ciNPT) can help manage wounds or incisions. However, guidelines for South Africa-specific use are limited. An in-person meeting was held with 10 experts to develop South Africa-specific therapy use recommendations for NPWTi-d and ciNPT. Panel members recommended NPWTi-d use for wounds in need of cleansing. Normal saline and a 10-min dwell time were recommended with the caveat that the instillation solutions and dwell times can be changed based on the wound bed condition and the features of the instillation solution. A negative pressure cycle of 2–3 h and a negative pressure of −125 mmHg were also recommended for NPWTi-d. In patients, incisions, and surgical procedures at high risk of developing surgical site complications, ciNPT use was recommended. These general recommendations serve as a framework for NPWTi-d and/or ciNPT use in South Africa and should be updated as more region-specific evidence becomes available.
The aim of this study was to assess the performance and safety of daily treatment with a 0.2% hyaluronic acid-based hydrogel (Hyalo4 Skin Gel) in patients with chronic and acute wounds. The primary endpoint was the amelioration rate after 14 days of treatment, defined as the percentage of patients showing improvement in at least one of the following wound characteristics: wound tissue type, exudate amount, or type. Secondary endpoints included assessments of the treatment's effects on wound bed type, exudate amount and type, and patients' quality of life (EQ-5D QoL), as well as its safety and ease of application. Data were collected up to 56 days of treatment. A total of 170 patients were enrolled. Wound bed amelioration was observed in 46.0% of the patients after 14 days. The amelioration rate increased from 0.291 after 7 days to 0.561 after 56 days. The treatment promoted wound healing, increased granulation tissue formation, and normalized exudate levels. Additionally, QoL significantly improved, and the product was deemed easy to apply and safe, with no serious treatment-related adverse events reported. Being effective in enhancing the re-epithelialization of both acute and chronic wounds, Hyalo4 Skin Gel emerges as a promising strategy, improving clinical outcomes across a wide range of patients.
This integrative review aimed to describe the postoperative wound care practices and knowledge of nurses in acute care settings. Whittemore and Knafl's framework was used to identify and synthesise relevant studies. Full-text, primary articles published after 2000, focusing on postoperative wound care by nurses in hospital settings, were included. Quality appraisal was undertaken using the Mixed Methods Appraisal Tool (MMAT) for qualitative and quantitative studies and the Standards for QUality Improvement Reporting Excellence (SQUIRE) 2.0 for quality improvement (QI) studies. Five databases were searched (MEDLINE, Scopus, CINAHL, Embase and Web of Science) in August 2024. Of the 5329 studies, 36 articles were included. Inductive content analysis was used for data synthesis. Three categories were identified: Variation in using a holistic approach impacts optimal wound care practice, nurses' surgical wound care practices are shaped by individual factors, organisational support, and resource availability, and nurses' participation in surgical wound care is influenced by role clarity and multidisciplinary collaboration. In conclusion, this integrative review highlights that acute care nurses predominantly focused on technical dressing procedures with limited emphasis on comprehensive assessment, documentation, nutrition and patient education. Therefore, adopting a more holistic approach in surgical wound care could minimize practice variations among nurses.
This study aimed to gain clinician consensus on which signs/symptoms reported to be indicative of biofilm in chronic wounds are likely to be so. An international, two-round eDelphi process including wound care clinicians ran from December 2023 to February 2024. Participants rated 26 items on a 9-point Likert scale. Consensus to include: ≥ 70% of respondents rate an item 7–9, ≤ 15% rate it 1–3. Consensus to exclude: ≥ 70% of respondents rate an item 1–3, ≤ 15% rate it 7–9. Eleven items (visual indicators [a shiny, slimy, persistent layer, easily removed, returns quickly without frequent intervention]; failure to respond to antimicrobials; infection > 30 days duration; poor quality granulation tissue; stalled wound despite optimal management; persistent/prolonged inflammation; wound > 6 weeks duration; soft tissue deterioration despite antimicrobials/debridement; signs of local infection; tunnelling/undermining; presence of slough) achieved consensus to include status. To our knowledge, consensus work on this topic has not previously been performed on such a wide scale. When examined alongside similar work, clinical opinion on the matter lacks coherence. We hope that these findings will help direct us toward greater cohesiveness. The work supports a need for research to quantify the predictive abilities of signs and symptoms reported to be indicative of biofilm in chronic wounds.
In England, diabetes-related foot ulcers and related amputations equate to approximately 1% of the National Health Service budget. Most of these costs are related to hospital admissions with diabetes-related foot ulcers, found to be 8.04 days longer when compared to those without ulcers. Although South Asian (SA) populations living in Western countries experience disproportionately high diabetes rates, they exhibit significantly lower prevalence of diabetes-related foot ulcers and lower-limb amputations compared to White European populations. This paradox remains underexplored, necessitating a scoping review to map existing evidence, elucidate disparities, and identify gaps. To explore the burden of diabetes-related foot ulcers among South Asians living in Western countries by examining their incidence, prevalence, and predisposing factors. Assessing clinical outcomes and lived experiences during the ulcerative phase and reviewing existing literature on recurrence and long-term post-healing complications. Following Joanna Briggs Institute methodology and reported in line preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews. A comprehensive search will be conducted across databases, and registered with open science framework. This will be the first scoping review to map diabetes-related foot ulcers burden among South Asians in Western settings. Clarifying incidence and outcome disparities, highlighting research gaps, and suggesting directions for future studies.
This study aimed to determine the level of knowledge of nurses caring for inpatients about medical device-related pressure injuries (MDRPI). This descriptive and cross-sectional study was conducted in a city hospital. A self-reporting survey was provided to a sample of 217 nurses. The research data were collected using the ‘Personal Information Form’ to assess the independent variables and the ‘MDRPI Knowledge Questionnaire’ to measure the dependent variable, which is the nurses' knowledge level regarding MDRPI. The mean total score of the MDRPI knowledge questionnaire of the participant nurses was found to be 12.82 ± 2.99 on a scale from 0 to 25. In the study, a statistically significant difference was found between the educational level and the clinic where the nurses worked and the mean scores of the questionnaire (p < 0.05). When examining the correct responses given by nurses to the survey items assessing their knowledge of MDRPIs, the highest correct response rate was 94.9% for the statement “The appropriate medical device with the right size should be chosen for the patient to avoid MDRPIs,” whilst the statement with the lowest correct response rate, at 6.5%, was “To avoid the occurrence of MDRPIs, the skin under and around the medical device should be checked at least once a day.” As a result, it was found that nurses' knowledge level about MDRPI was moderate.
Hypertrophic scars (HTSs) result from excessive collagen accumulation and impaired wound remodelling, leading to considerable aesthetic and functional concerns. Despite the availability of various treatment strategies, their clinical success remains limited, emphasising the need for alternative approaches. Human amniotic fluid (hAF), naturally enriched with cytokines and growth factors, has emerged as a promising biological material for tissue regeneration. This study investigated the therapeutic potential of two forms of hAF—pooled-frozen and pooled-frozen gamma-irradiated—in a rat model of hypertrophic scarring. Fifteen adult male Sprague–Dawley rats were randomly assigned to receive subcutaneous injections of either saline, pooled-frozen hAF, or pooled-frozen gamma-irradiated hAF at the wound margins on days 1, 3 and 5 following the induction of hypertrophic scars via talc powder application. After 21 days, wound healing was evaluated through histological and immunohistochemical analyses. Both treatment groups demonstrated significantly improved wound healing compared to the control group. Granulation tissue formation was enhanced in the treated groups, particularly in animals receiving gamma-irradiated fluid, which also showed superior collagen remodelling characterised by aligned and mature collagen bundles. Both treatment groups demonstrated an increase in M2 macrophage density, as evidenced by elevated Arg+/CD68+ cell ratios; however, this effect was more pronounced in the gamma-irradiated group, indicating a stronger shift towards a regenerative immune profile. Enhanced reepithelialisation, increased hair follicle density and reduced scar thickness were also observed. These findings suggest that gamma-irradiated hAF provides a more effective and minimally invasive therapeutic option for modulating scar formation and improving wound healing outcomes, supporting its potential translation into clinical applications for the management of hypertrophic scars.
Surgical site infections (SSI) and surgical site complications (SSC) significantly impact surgery outcomes, increasing hospital stays and mortality rates, and negatively affecting patients' quality of life. Closed-incision negative pressure therapy (ciNPT) emerged as a prophylactic strategy to reduce these complications. However, its applicability across different surgical procedures remains unclear. A scoping review was conducted to synthesise the available evidence on the use of ciNPT in different surgical contexts. A multidisciplinary panel of experts from different surgical specialties was assembled to identify patient risk factors for SSCs specific to each modality. Surgical procedures were categorised based on anticipated SSC rates and the impact of SSI. A decision diagram was finally developed, providing tailored recommendations for ciNPT use according to individual surgical circumstances. The findings of the review indicate that ciNPT effectively reduces SSI and SSC in most surgical procedures. Key patient-related factors influencing outcomes, such as age, obesity, and malnutrition, were outlined. Additionally, a specialty-based list of surgical procedures was compiled, specifying whether ciNPT is recommended, not recommended, or conditionally recommended based on specific criteria. This study underscores the benefits of ciNPT and provides a comprehensive guide to its application across several surgical specialties, aiming to optimise patient management and inform clinical practise.
Soft silicone multi-layer dressings are commonly used for pressure ulcer (pressure injury) prevention, yet their effectiveness varies based on design, construct, and material properties. This study evaluated the protective efficacy of a new multi-layer dressing, ALLEVYN COMPLETE CARE (ACC, Smith & Nephew Limited), which incorporates an advanced structure facilitating the dissipation of shear forces through internal layer-on-layer frictional sliding within the dressing. Using a combination of experimental frictional energy absorber effectiveness (FEAE) testing and computational finite element modelling, we quantified the capacity of this dressing to mitigate strain and stress concentrations in the soft tissues of the supported posterior heel. The dressing demonstrated considerable frictional sliding between its adjacent layers, resulting in FEAE = 93% under simulated, clinically relevant usage conditions. This was associated with the dissipation of shear forces and alleviation of strain/stress concentrations in the skin and underlying soft tissues below the dressing. The dressing completely eliminated the stress and strain peaks at the top quartiles of the strain/stress domain (with reference to a no-dressing case). This work provided valuable insights into advanced testing methods and beneficial design principles for pressure ulcer prevention dressings. Earlier investigations concluded that a previous-generation ALLEVYN LIFE dressing achieved high levels of FEAE and thus provided protection. Our findings here establish that the next-generation dressing, ACC, demonstrates even greater protective capacity.
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.
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