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The management of diabetic foot ulcers in patients with peripheral artery disease remains challenging. Human placenta-derived cells (PDA-002), a mesenchymal stromal cell-like population obtained from full-term placental tissue, possess angiogenic and tissue regenerative properties. Participants were stratified based on peripheral artery disease status. A total of 159 individuals were randomly assigned to receive intramuscular PDA-002 at one of three doses (3 × 106, 10 × 106 and 30 × 106 cells) or a placebo. This Phase 2 multi-center, randomised, double-blind, placebo-controlled trial evaluated adults with chronic diabetic foot ulcers with and without peripheral artery disease. The primary efficacy endpoint was the proportion of participants achieving complete wound closure of the index ulcer within 3 months, with sustained closure maintained for an additional 4 weeks. PDA-002 was well-tolerated, with no treatment-related serious adverse events. Intramuscular PDA-002 treatment achieved the highest efficacy at the 3 × 106 cell dose within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4-week durability endpoint that surpassed the U.S. Food and Drug Administration's recommended 2-week sustainability criterion. PDA-002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re-treatment.
Trial Registration: ClinicalTrials.gov identifier: NCT # 02264288
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.
Limited evidence exists regarding the effectiveness of learning approaches in supporting interprofessional wound care education transnationally. The aim of this pilot study was to explore the feasibility and preliminary impact of an international, online interprofessional masterclass in supporting baccalaureate health students' learning about wound care. Data were collected using multiple methods including quantitative survey, qualitative focus groups, and interviews with baccalaureate nursing, pharmacy, dietetics, podiatry and paramedicine students from two universities based in Australia and Northern Ireland. A retrospective pre-test design was used. A survey retrospectively assessed students' self-reported confidence and understanding before and after the masterclass, while qualitative methods explored students' experiences of interprofessional learning and wound care. Self-reported improvements in students' understanding of wound assessment and management, as well as heightened awareness of interprofessional contributions to patient care indicated the potential value of this interprofessional and international collaboration in supporting wound care education. Qualitative analysis identified four themes: recognising a wound is a person's wound; comparing international healthcare practices; fostering learner engagement; interprofessional recognition, acknowledgment, and understanding of each profession's roles, contributions and expertise. This pilot study has highlighted key issues to be addressed in future research examining the impact of a collaborative online international initiative on baccalaureate students' interprofessional learning about wound care.
Pressure injuries (PIs) remain a problem for patient safety and the sustainability of healthcare systems. Difficulties persist in their assessment, prevention and monitoring by multidisciplinary teams. International recommendations point to this problem as a priority area for resolution in terms of patient safety. Research on the subject has been positive, resulting in several guidelines for clinical practice, but professionals' adherence remains below what is expected for their implementation. This scoping review aimed to identify interventions that increase multidisciplinary teams' adherence to the prevention and management of PIs between hospitals and the communities. The search was carried out in the MEDLINE (via PubMed), CINAHL, Scopus, Web of Science, JBI, Cochrane and grey literature databases by two independent reviewers, and led to the identification of 16 articles that met the eligibility criteria and made it possible to answer the research question. Strategies to improve adherence by health professionals include the creation and training of multidisciplinary teams, the implementation of new risk assessment models, Wound Boards, injury prevention reminders, video consultation apps, multidisciplinary rounds, documentation and recording. No studies were identified that assessed staff adherence to interventions aimed at preventing and managing PIs in the continuum between hospitals and communities, which is suggestive of the need for further research in this area.
The Wound-QoL assesses patients' health-related quality of life. Quick and valid interpretation of the results is crucial, but no thresholds have yet been established. Additionally, counting top box responses might be a quick approximation to the Wound-QoL score itself. The aim of this study was to develop Wound-QoL bands (i.e., thresholds) and to analyse top box responses. Patients from European countries completed the Wound-QoL and a global question. We grouped patients' Wound-QoL scores and mapped these on the global question score. Upon this, we developed sets of Wound-QoL bands and calculated the weighted kappa (κ) coefficient of agreement for each set. Moreover, we analysed the correlation of the sum of top box responses with patients' Wound-QoL. The 305 patients (mean age: 68.5 years; 52.8% male) had most frequently leg ulcers (49.2%). The final set of Wound-QoL bands with the highest κ coefficient (0.564 and 0.550) was 0–0.25, not at all/rarely impaired; > 0.25 to 1, a little; > 1 to 2, moderately; > 2 to 3, quite a lot; > 3 to 4, very much. Top box responses showed strong correlation with the Wound-QoL scores (0.961–0.961). We are confident that the Wound-QoL bands will facilitate interpretation of Wound-QoL data in routine care as well as in research.
Skin allografts are essential in managing complex wounds, yet their availability is limited by low post-mortem donation rates. Skin harvested during body contouring surgeries offers a novel and sustainable source to expand tissue supply. We conducted a retrospective descriptive study at the Tarapacá Skin and Tissue Bank from January 2022 to December 2024. All donations from body contouring surgeries were processed as cryopreserved total skin allografts following national tissue banking standards. Variables included donor demographics, harvested area, units produced, microbiological results, and discard rates. To describe clinical performance, we present our group's initial clinical series of treated patients. From 248 living donors (mean age 41.3 years), 81 293 cm2 of skin generated 2050 units. The discard rate was 27%, mainly due to a storage failure and isolated microbial contamination. Clinically, all patients achieved complete initial graft take, followed by gradual necrotic eschar formation at an average of 21 days. Eschar removal revealed vital tissue firmly adhered to the recipient bed, rich in fibroblasts and neovascular structures. Subsequent management included either escharectomy with split-thickness autografting over the neodermis, or spontaneous eschar lysis and skin regeneration, with the graft functioning as a dermal regenerator. This model increases tissue availability while providing allografts with both coverage and dermal regenerative properties.
The opioid crisis has been exacerbated by xylazine, a veterinary sedative increasingly present in illicit drugs. Xylazine causes severe skin wounds that increase the risk of morbidity. Current wound classification systems fail to address the unique features of this injury, creating a need for a tailored assessment and treatment approach. We developed the HEAL-X classification system to standardise evaluation and treatment of xylazine-associated wounds. The system grades wounds using five criteria: History, Extent, Appearance, Location, and Xylazine-specific features. Grades range from 0 (normal skin) to 5 (underlying structure involvement). HEAL-X integrates principles from existing classifications while focusing on xylazine-specific pathology. This novel system was developed by an inter-disciplinary panel and requires empirical validation through clinical application and further research. HEAL-X provides a framework for grading xylazine-associated wounds, guiding treatment from lower-grade wounds to severe cases. This system aligns with the unique characteristics of xylazine wounds, offering a more tailored approach than any existing models individually. HEAL-X addresses a critical gap in managing xylazine-associated wounds. It offers a standardised tool to evaluate wound severity, guide treatment, and improve patient outcomes. As xylazine use rises and further research refines prognostic indicators and treatment outcomes, HEAL-X provides a framework on which to build.
Chronic and non-healing wounds are a global health issue with limited effective treatments. Wound care costs continue to rise, highlighting the need for new therapies. Medicinal plants, particularly African species, show promise for enhancing wound healing. This review analysed 93 studies and identified 37 relevant to wound healing, covering 39 plant species. Ten species were identified for their rich phytochemical content, specifically flavonoids, terpenoids, and alkaloids (plant-derived compounds). These compounds act synergistically, enhancing the wound healing process at each stage. Flavonoids reduce inflammation and support tissue turnover, while terpenoids enhance collagen production and wound closure. Alkaloids offer antimicrobial benefits and support wound contraction. Notable plants include Ageratum conyzoides and Aspilia africana (Asteraceae family); promoting haemostasis by lowering plasma fibrinogen and enhancing platelet-derived growth factors; Withania somnifera (Solanaceae); and Entada africana (Fabaceae), effectively regulating inflammation. In the proliferative phase, Ocimum gratissimum (Lamiaceae), Calendula officinalis (Asteraceae), and Centella asiatica (Apiaceae) although C. officinalis is native to Southern Europe, and C. asiatica an Asian-native; they are widely used in African traditional medicine and included here for their relevance in African wound healing practices; Justicia flava (Acanthaceae), Alternanthera sessilis (Amaranthaceae), and Acalypha indica (Euphorbiaceae); play key roles in enhancing collagen production, angiogenesis, and re-epithelialisation. This comprehensive analysis highlights the role of African medicinal plants in wound healing and their potential to improve wound care therapy.
Chronic leg ulcers present a significant clinical challenge due to their prolonged healing time and high recurrence rates. This prospective, multi-centre, non-randomised, observational study investigated the efficacy of a dermal regeneration template in improving skin graft integration for chronic leg ulcer treatment. Thirty patients were enrolled, with a control group receiving only skin grafts to evaluate the additional benefits of the template. Patients were assessed for pain levels, healing rates, wound retraction, pruritus, dressing type, analgesic use, complications, surgeon-evaluated wound recovery using the Vancouver scale, quality of life through the EuroQol questionnaire and photographic wound documentation. At 18 months, 70.0% of patients achieved at least a 50% reduction in wound surface area and 56.7% experienced complete wound closure. Significant improvements were observed in pain and discomfort (p = 0.0125), mobility (p = 0.0267), pain levels (p = 0.0340), vascularity (p = 0.0275) and overall wound reduction (p = 0.0368). The control group demonstrated lower wound reduction and complete healing rates, reinforcing the superior effectiveness of the dermal regeneration template in combination with skin grafting. This study highlights the potential of this approach to accelerate wound healing, reduce patient discomfort and enhance quality of life compared to traditional skin grafting alone.
Hypertensive ulcer, also known as Martorell ulcer, comprises cutaneous lesions induced by microvascular arteriolitis, which leads to ischaemia and subsequent ulceration in patients with long-standing hypertension. These lesions predominantly affect women and have traditionally been considered rare; however, recent studies suggest that their prevalence may be significantly higher than previously assumed. Early and accurate diagnosis is crucial, as these ulcers are often mistaken for lesions of alternative aetiologies, such as venous ulcers or pyoderma gangrenosum, thereby contributing to their frequent underdiagnosis. Moreover, this pathology is associated with pronounced painful symptomatology and exhibits a suboptimal response to both analgesic regimens and conventional wound care protocols, potentially necessitating alternative management strategies. This diagnostic delay or misdiagnosis consequently escalates the utilisation of healthcare resources. The primary objective of this study was to develop a predictive model for the differential diagnosis of Martorell ulcers. The investigation entailed a systematic case review, during which the most prevalent signs and symptoms, medical histories and demographic characteristics associated with these lesions were scrutinised. A comprehensive descriptive and inferential analysis of the various variables was performed, followed by a binomial logistic regression to construct the predictive model. In this logistic regression analysis, systolic blood pressure (SBP) emerged as the principal predictor among the cases examined. Additionally, pain intensity was incorporated into the predictive model as a clinically relevant variable, thereby confirming its utility in conjunction with SBP for the identification of this pathology. These findings underscore the importance of integrating key variables, such as elevated SBP and severe pain, into diagnostic tools to enhance early detection and clinical management of Martorell ulcers.
Cutaneous anthrax is a zoonotic bacterial infection that mostly involves the head, neck, and upper extremities. Periorbital involvement of cutaneous anthrax is a rare presentation that can lead to severe irreversible complications. Herein, we describe a 2.5-year-old girl with periorbital anthrax cellulitis. She presented with a severe swelling on the right side of her face and an ulceronecrotic lesion above the right eyebrow. After receiving an appropriate antibiotic regimen, her condition improved and she was discharged without any intraocular complications.
We aimed to systematically review and quantify risk factors for first-ever diabetes-related foot ulcer (DFU). Four English and three Chinese electronic databases were searched for cohort and case–control studies reporting risk factors for first-ever DFU. Two researchers independently screened titles, abstracts and full text, extracted data and assessed the quality of included studies. Meta-analyses were performed for risk factors reported in at least two studies, using unadjusted odds ratios and standardised mean differences for dichotomous and continuous variables. Of 6736 potential studies screened, 23 were included in the meta-analysis and 24 in the systematic review. Twenty-eight significant risk factors for first-ever DFU were identified, including older age, obesity, male gender, unmarried status, alcohol consumption, current smoking, insufficient physical activity, longer diabetes duration, increased HbA1c, fasting plasma glucose, creatinine and triglyceride, decreased eGFR and high-density lipoprotein, high vibration perception threshold, albuminuria, low ankle-brachial pressure index ratio, cardiovascular, cerebrovascular and peripheral artery disease, retinopathy, nephropathy, neuropathy, myocardial infarction, foot deformity, skin dryness, insulin treatment and anti-hypertensive treatment. This study provides the first comprehensive synthesis of risk factors for first-ever DFU. Identifying high-risk individuals based on these factors can enhance early intervention strategies, reducing the burden of DFU in diabetes management.
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 study aims to examine the self-efficacy levels of nurses in the management of pressure ulcers (PUs) and the demographic and professional factors affecting this. This cross-sectional and descriptive study was conducted with 436 nurses. Data were collected between January and April 2024, using the Nurse Identification Form and the Pressure Ulcer Management Self-Efficacy Scale (PUM-SES). In the study, the total mean score of the PUM-SES was found to be 58.77 ± 18.07 (min–max: 0–100). The mean scores of the sub-dimensions of the scale were assessment 57.54 ± 20.60, planning 59.14 ± 21.15, supervision 57.16 ± 21.86, decision making 60.02 ± 19.19 (min–max: 0–100). In addition, it was observed that the total scores of the PUM-SES were significantly higher for nurses who were 34 years old and older, had worked in the unit for 3 years or more and worked in intensive care clinics. Findings showed that nurses generally had a moderate PUM-SES score. Sociodemographic variables explained only 3.9% of the total variance. Age was significant in the sub-dimensions of surveillance (β = 0.241, p = 0.001) and decision-making (β = 0.162, p = 0.03); while the unit worked had a significant and negative effect on all sub-dimensions and the total score (β = −0.159, p = 0.001). The results obtained suggest that professional experience and the working environment may have an effect on the cognitive competence of nurses. Therefore, it is recommended that training programs be developed to support nurses' decision-making processes and professional competence.
The primary aim of this study was to evaluate the impact of the polyhexamethylene biguanide (PHMB) care bundle on the occurrence rates of surgical site infections (SSIs) in paediatric and neonatal cardiac surgery, addressing a critical gap in paediatric-specific infection prevention protocols. A retrospective cohort study included patients under 18 years old who underwent cardiac surgery at IRCCS Policlinico San Donato. Cohort A (n = 117) received the PHMB care bundle from April to December 2023, while Cohort B (n = 801) received conventional care from September 2020 to March 2023. The 1:1 propensity score matching was used to balance covariates between cohorts, resulting in two comparable cohorts (Cohort A = 114 patients and Cohort B = 112). The study found a significant reduction in SSIs among patients receiving the PHMB care bundle compared with those receiving conventional care (1.8% vs. 7.1%, p = 0.048). The comprehensive nature of the PHMB care bundle, including educational programs, preoperative and postoperative antimicrobial treatments, and consistent application of best practices, was instrumental in achieving these outcomes. Implementing antimicrobial care bundles could significantly reduce SSIs in paediatric cardiac surgery. Future research is needed to refine the tested bundle with prospective approaches.
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.
The objective of this study was to test the validity, reliability and dimensionality of the Norwegian version of the Cardiff Wound Impact Schedule (CWIS), a measure for wound-specific health-related quality of life. The Norwegian CWIS and a 36-item short form health survey (SF-36) were completed by 204 patients with hard-to-heal wounds on the lower extremity. The questionnaires were filled in at three time points over 8–14 weeks (T0, T1, T2). The Patients Global Impression of Change (PGIC) was completed at T1 and T2. Demographic and clinical data were collected at T0 and T2. The three-factor model of the CWIS showed an acceptable fit to the observed data, and the dimensionality was clear as long as two correlated error terms were accepted and four items were removed (χ 2 = 426.64, p = 0.000, df = 204, χ 2/df = 2.09, RMSEA = 0.074, SRMR = 0.066, CFI = 0.900, TLI = 0.880). Correlation analyses showed significant associations between the CWIS and SF-36 (0.350**–0.766**), PGIC (−0.277**), wound size (−0.156**), general wound pain intensity (−0.371**) and pain intensity at wound change (−0.240**); all aligned with the expected directions. The intraclass correlations indicated good to excellent test–retest reliability (0.724**–0.951**). The internal consistency ranged from acceptable to excellent (α = 0.78–0.89, ρc = 0.79–0.89). While the questionnaires' ability to detect wound-related change was low, it was adequate for differentiating between healed and non-healed ulcers. The Norwegian version of the CWIS demonstrated good reliability and construct validity, making it suitable for evaluating HRQoL in patients with hard-to-heal wounds. However, some modifications were made to achieve an acceptable model fit.
This study compares the performance of various wound classification systems to determine which system most effectively predicts amputation risk in diabetic foot ulcer (DFU) patients. Additionally, it identifies the key clinical and socioeconomic factors that influence this risk. A total of 616 DFUs from 400 outpatient participants in a prospective cohort study were followed over 6 months. Ten machine learning (ML) algorithms were employed to evaluate the predictive accuracy of various wound classification systems. The SHapley Additive exPlanations (SHAP) method was used to interpret the predictions of the selected model. The DIAFORA (diabetic foot risk assessment) and WIFI (Wound, Ischaemia and foot Infection) classification systems demonstrated the highest predictive power for predicting amputation within 6 months. SHAP analysis revealed that wound penetration to bone, presence of ischaemia and infection, renal failure, delayed first specialist visit, longer diabetes duration, high baseline HbA1c, low education levels and high body mass index were significant risk factors for amputation. Conversely, higher education levels served as a protective factor. Occupation showed variable effects, with private-sector employment associated with increased risk, while being a housewife was linked to lower risk. Infection and ischaemia are significant factors affecting DFU outcomes. Addressing treatment adherence barriers and implementing tailored interventions that consider patients' occupational needs can reduce amputation rates.
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