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A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi‐centre clinical trial

Abstract

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.

Evidence related to a vegetarian diet and metabolic dysfunction-associated steatotic liver disease: protocol for a scoping review

Por: Moss · K. · Gitman · V. · Pinto Sanchez · M. I. · Oczkowski · S. · Armstrong · D. · Jayakumar · S. · Karvellas · C. J. · Selzner · N. · Dionne · J.
Introduction

Metabolic dysfunction-associated fatty liver disease (MASLD) is the hepatic manifestation of metabolic syndrome and the leading cause of chronic liver disease worldwide. Given that there is no pharmacological treatment for MASLD, it is imperative to understand whether lifestyle modifications may improve biochemical and pathological outcomes. One commonly proposed dietary modification is the Mediterranean diet; however, vegetarianism may also be a promising intervention. Vegetarianism has been shown to be associated with reduced morbidity and mortality in metabolic syndrome outcomes in coronary artery disease and diabetes; however, the relationship between vegetarian diet and MASLD is less clear. In this scoping review, we will provide a comprehensive overview of the current body of evidence related to a vegetarian diet and MASLD.

Methods and analysis

The aim of this scoping review is to describe and summarise the current body of evidence related to MASLD and a vegetarian diet. This review will be conducted using Arksey and O’Malley’s framework. The literature review will be conducted using the following databases: SCOPUS, Web of Science, CINAHL-Plus, Cochrane Library and Medline. No restriction will be made on publication date. Included studies will encompass clinical trials and observational designs that examine effects or association of vegetarian diet in adults (≥16 years) and report on the incidence, prevalence or progression of MASLD. Grey literature, non-human studies and articles focusing on changes in a specific food or nutraceutical will be excluded. Articles must have an English-language abstract available to be considered for inclusion. Screening and data extraction will be conducted by two independent reviewers. The findings will be summarised with descriptive statistics.

Ethics and dissemination

Approval from a medical ethics committee is not required for this review. Once the review is complete, the findings will be submitted to a peer-reviewed journal.

Predicting pressure injury risk in hospitalised patients using machine learning with electronic health records: a US multilevel cohort study

Por: Padula · W. V. · Armstrong · D. G. · Pronovost · P. J. · Saria · S.
Objective

To predict the risk of hospital-acquired pressure injury using machine learning compared with standard care.

Design

We obtained electronic health records (EHRs) to structure a multilevel cohort of hospitalised patients at risk for pressure injury and then calibrate a machine learning model to predict future pressure injury risk. Optimisation methods combined with multilevel logistic regression were used to develop a predictive algorithm of patient-specific shifts in risk over time. Machine learning methods were tested, including random forests, to identify predictive features for the algorithm. We reported the results of the regression approach as well as the area under the receiver operating characteristics (ROC) curve for predictive models.

Setting

Hospitalised inpatients.

Participants

EHRs of 35 001 hospitalisations over 5 years across 2 academic hospitals.

Main outcome measure

Longitudinal shifts in pressure injury risk.

Results

The predictive algorithm with features generated by machine learning achieved significantly improved prediction of pressure injury risk (p

Conclusions

These data could help hospitals conserve resources within a critical period of patient vulnerability of hospital-acquired pressure injury which is not reimbursed by US Medicare; thus, conserving between 30 000 and 90 000 labour-hours per year in an average 500-bed hospital. Hospitals can use this predictive algorithm to initiate a quality improvement programme for pressure injury prevention and further customise the algorithm to patient-specific variation by facility.

Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double‐blind, placebo‐controlled trial

Abstract

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).

Using spatial video geonarratives to improve nursing care for people who use drugs and experience homelessness: A methodology for nurses

Abstract

Background

People who are insecurely housed and use drugs are disproportionately affected by drug poisonings. Nurses are uniquely positioned to utilize harm reduction strategies to address the needs of the whole person. Needle debris encompasses drug paraphernalia discarded in public spaces. Studying needle debris provides a strategic opportunity to identify where drugs are being used and target public health strategies accordingly.

Aim

Our aim in this article is to illustrate how spatial video geonarratives (SVG) combined GPS technology interviews, and videos of locations with needle debris, can elicit valuable data for nursing research.

Methods

Using SVG required knowledge of how to collect data wearing cameras and practice sessions were necessary. A Miufly camera worn at waist height on a belt provided the stability to walk while interviewing stakeholders. We wore the cameras and conducted go-along interviews with outreach workers, while filming the built environment. Upon completion of data collection, both the interview and GPS information were analysed using Wordmapper software.

Conclusions

This methodology resulted in data presented uniquely in both a visual map and narrative. These data were richer than if a single modality had been used. These data highlighted specific contextual factors that were related to the location of needle debris, which created opportunities for nursing interventions to support people experiencing vulnerability.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis

Abstract

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.

Prevalence, correlates and common methods of non-suicidal self-injury in South Asia: a systematic review

Por: Haregu · T. · Chen · Q. · Arafat · S. M. Y. · Cherian · A. · Armstrong · G.
Introduction

The dynamics of self-harm vary substantially around the world, yet it is severely under-researched outside of a small number of high-income ‘Western’ countries. South Asia is disproportionately impacted by suicide, yet we know less about non-suicidal self-injury (NSSI) in the region.

Objective

To review and summarise evidence on the prevalence, correlates and common methods of NSSI in South Asia.

Methods

We searched Medline, Embase and PsycINFO for the period 1 January 2000 to 31 August 2023, for peer-reviewed observational studies. A total of 11 studies from eight South Asian countries that reported prevalence and/or correlates of NSSI were included in this review. We assessed the quality of the studies using the Study Quality Assessment Tools for Observational Cohort and Cross-Sectional Studies. We used meta-regression to describe the sources of heterogeneity. Abstracted data were summarised using thematic synthesis.

Results

For non-clinical populations, the 12-month prevalence of NSSI ranged from 3.2% to 44.8%, and the lifetime prevalence ranged from 21% to 33%. For clinical populations, the 12-month prevalence of NSSI ranged from 5% to 16.4%, while the lifetime prevalence ranged from 2% to 27%. Male sex, unemployment, financial stress, history of suicidal behaviour and depression were associated with a higher risk of NSSI. Better access to counselling services, higher self-esteem and self-knowledge were associated with a lower risk of NSSI.

Conclusion

The burden of NSSI in South Asia appears to be high in both clinical and non-clinical populations. Further research, especially with general population samples, is needed to build evidence on the epidemiology, context and meaning of NSSI in South Asia to inform the design of context-specific interventions.

PROSPERO registration number

CRD42022342536.

Most individuals with diabetes‐related foot ulceration do not meet dietary consensus guidelines for wound healing

Abstract

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.

An Evaluation of the Multifactorial Model of Cancer-Related Cognitive Impairment

imageBackground 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.
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