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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.
Annually, 49 million people worldwide are impacted by lower extremity ulcers (LEUs). Diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) are the most common LEUs. Negative pressure wound therapy (NPWT) has emerged as an effective intervention for complex wounds, offering numerous favourable wound healing outcomes. The objective of this study was to evaluate the effectiveness of single-use NPWT (sNPWT) versus traditional NPWT (tNPWT) for wound closure in LEUs. Real-world data was obtained from the US-based Net Health outpatient database between January 2014 and October 2020 and included patients with LEUs (DFU or VLU) who had been treated with sNPWT or tNPWT. The rate of wound closure and time to wound closure were selected as endpoints. The wound closure rate was significantly higher for all LEUs (p = 0.039), VLUs alone (p = 0.003) and there was no difference for DFU (p = 0.90) that were treated with sNPWT versus tNPWT. The median time to wound closure was significantly shorter for sNPWT (114 days) compared to tNPWT (140 days, p < 0.01). Using sNPWT was associated with significantly higher wound closure rates and shorter time to wound closure. The results provide supportive evidence for using sNPWT for LEUs, demonstrating the opportunity to directly decrease the clinical burden of LEUs on patients. Subgroup analysis revealed a significant difference in wound closure rates for VLU, while no significant difference was observed for DFU. The overall LEU findings may be attributed to differences in the mechanisms of action between the two devices.
Leishmania spp. are intracellular protozoan parasites responsible for leishmaniasis, a globally prevalent vector-borne disease transmitted by phlebotomine sandflies. Within vertebrate hosts, the parasites preferentially infect macrophages and dendritic cells, leading to cell lysis and the formation of disfiguring lesions. Current treatment regimens are hampered by high toxicity, prolonged administration protocols, and severe side effects, underscoring the need for safer and more effective therapeutic alternatives. Mesenchymal stem cells (MSCs), multipotent non-haematopoietic progenitors with fibroblast-like characteristics, possess self-renewal capacity and the ability to differentiate into various functional cell types. Their intrinsic immunomodulatory and antimicrobial properties have positioned MSCs as promising candidates for combating infectious diseases, including leishmaniasis. This review systematically synthesises experimental evidence on the effects of MSCs on Leishmania parasites and the associated lesions, investigates the potential healing mechanisms of MSCs in the context of Leishmania infection, and outlines future research directions in this evolving field. A comprehensive literature search—spanning Scopus, PubMed, Web of Science, and Google Scholar up to 31 May 2024—identified 11 relevant studies: eight from Iran, two from Brazil, and one from Turkey. While Brazilian investigations utilised L. amazonensis, the others focused primarily on L. major, a leading cause of cutaneous leishmaniasis (CL). Across these studies, MSC-based therapy has shown immunomodulatory and antiparasitic effects, influenced by factors such as cell dosage, timing, route of administration, and the parasite burden. Despite promising findings, variability in experimental designs and outcomes highlights the early and exploratory stage of MSC application in CL therapy. Rigorous and standardised research is urgently needed to validate the therapeutic potential of MSCs and to support their clinical translation for leishmaniasis treatment.
Venous leg ulcers (VLUs) are traditionally managed with standard-of-care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real-world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (n = 312) or collagen/oxidised regenerated cellulose (ORC) (n = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM-treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (p = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM-treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real-world patient cohort.
Non-healing venous leg ulcers represent a significant healthcare problem that accounts for about $32 billion of spending in the US alone. Consequently, novel treatment strategies represent a major unmet need. The current study (part one of Phase II study [NCT04647240]) assesses the safety, tolerability and efficacy of the use of cell-free human amniotic fluid in treating venous leg ulcers that did not heal following the correction of venous reflux. Patients received cell-free amniotic fluid injections in and around the wound either weekly or biweekly over 12 weeks. Primary outcomes included safety, tolerability and efficacy assessed by complete wound closure, wound area reduction and pain reduction. Eleven patients met enrollment eligibility, and nine completed the study. Five patients achieved complete wound closure by week 12. The average percent reduction in wound area was 83.7%, and pain scores were significantly lower by the study endpoint. No difference was observed in wound healing rates between weekly or biweekly treatment, but bi-weekly treatment was associated with nominally faster recovery. Patients tolerated the treatment, and no side effects were reported. These results indicate that cell-free amniotic fluid injection is a feasible, safe and effective treatment for non-healing venous leg ulcers.
Ankle Brachial Pressure Index (ABPI) measurement has long been considered the gold standard of vascular assessment for people with lower limb ulceration. Despite this, only around 15% of patients in the United Kingdom who require an ABPI measurement undergo the assessment. The Lanarkshire Oximetry Index (LOI) is a cheaper and arguably more accessible approach to vascular assessment and was initially proposed as an alternative to the ABPI in 2000. No synthesis of evidence related to the LOI has been performed since its introduction into the literature. Primary studies were sought to determine the clinimetric properties of the LOI and its level of agreement with ABPI assessments. Systematic searches of MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, BNI, ProQuest Health and Medicine, Science Direct, Google Scholar and the British Library (online search) were conducted. Reference lists of identified studies were also reviewed to identify additional studies. Three primary studies met the inclusion criteria, reporting data from 307 patients and 584 limbs assessed using both the LOI and ABPI. All three studies reported fair to moderate kappa values for interrater reliability (κ = 0.290–0.747) and statistically significant positive correlation coefficients (r = 0.37, p < 0.001 in two studies) between the LOI and ABPI. The combined data from the three studies indicated a sensitivity of 52% (41.78–62.1, 95% confidence interval [CI]) and specificity of 96.08% (93.4–97.9, 95% CI) for the LOI using the ABPI as a reference. Additional data are required to indicate the safety of the LOI in practice. Data are also required to determine if the LOI is more acceptable to clinicians compared to the ABPI and whether there are any barriers/enablers to its implementation in practice. Given the relatively low specificity of the LOI, it may be beneficial to combine measurement of the LOI with a subjective clinical risk assessment tool to improve the sensitivity of this alternative approach to vascular assessment.
The incidence of squamous cell carcinoma (SCC) is on the rise, making it a significant global health concern. Environmental risk factors are crucial to the development of SCC. This study sought to examine comprehensively the impact of these factors on the onset of SCC. We conducted a cross-sectional study involving 480 participants at Beijing tertiary care hospital. Utilizing structured questionnaires, data on demographics, environmental exposures, medical history and clinical characteristics were collected. The cohort was composed of 272 men (56.67%) and 208 women (43.33%). The majority (44.38%) were between ages of 41 and 60, and Type III skin predominated (34.79%). Most of the participants belonged to the middle socioeconomic class (60.83%). ‘Vegetarian’ dietary habits (46.67%) were prevalent, as was the ‘Sedentary’ lifestyle (49.79%). Regarding environmental exposures, moderate sun exposure of 3 to 5 h per day (54.58%) and UV protective eyewear (30.83%) were prevalent. The majority (69.58%) of respondents indicated ‘Never’ exposure to carcinogens. A variety of wound characteristics were observed, with ‘non-smokers’ (64.17%) dominating. Most SCC lesions were located on the extremities (40.21%), lasted less than 6 months (44.38%) and measured 1–3 cm (39.79%). The majority (54.58%) did not have a history of cutaneous injuries. Our research uncovered substantial relationships between SCC and numerous environmental variables, gender, Fitzpatrick skin type, occupation, duration of sun exposure, exposure to carcinogens, dietary practices, history of skin wounds, wound location, duration, size and depth were significantly associated with the onset of SCC. These results highlighted the complexity of SCC aetiology and need for individualized prevention and treatment strategies.
Pressure injury (PrI) prevention guidelines recommend 2-h repositioning intervals in healthcare settings, requiring significant nursing time investment. We analysed the cost-effectiveness of PrI prevention protocols with 2-, 3- and 4-h repositioning intervals in US nursing homes according to ‘Turn Everyone and Move for Ulcer Prevention’ (TEAM-UP) randomized controlled trial findings. Markov modelling compared 2-, 3- and 4-h repositioning intervals, controlling for other practice guidelines, to prevent PrIs in nursing home residents from a US health sector perspective over one year using TEAM-UP trial data for model structure, sampling and parameterization. Costs, captured in 2020 US dollars, and quality-adjusted life years (QALYs) were used to derive an incremental cost-effectiveness ratio and net monetary benefit (NMB) at $50 000/QALY-$150 000/QALY cost-effectiveness thresholds. Sensitivity analyses tested model uncertainty. Repositioning intervals between 3 and 4 h were cost-effective based on reduced costs at slightly lower QALYs than 2 h at a $50 000/QALY threshold, and the NMB of 4-h repositioning was also more efficient than at 3 h ($9610). Repositioning labour cost and prevention routines were among the most sensitive parameters. Sensitivity analyses demonstrated that 3- and 4-h intervals were cost-effective in over 65% of simulations at any cost-effectiveness threshold. Repositioning intervals of 3 to 4 h have potential to reduce nursing time costs without significant decrements in clinical benefits to nursing home residents. Clinical guidelines for PrI prevention should be updated to reflect TEAM-UP clinical and economic findings. Facilities can use cost-savings recuperated from nursing time to deploy to other patient safety priorities without seriously jeopardizing PrI safety.
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