Conectar
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
Major lower limb amputation, defined as an amputation above the level of the ankle joint, is a substantial cause of morbidity and mortality. Limited data exist on the burden, aetiology and outcomes of major lower limb amputations in sub-Saharan Africa (SSA). This is despite increasing rates of diabetes, peripheral arterial disease and trauma, with further projected increases in these conditions, which often precede major lower limb amputation. The Regional Assessment of Amputations in sub-Saharan Africa (RAMPs) study aims to address this knowledge gap by performing a multicentre, prospective study of major lower limb amputations across the region.
We describe a prospective, multicentre observational cohort study enrolling patients undergoing major lower limb amputation at hospitals in SSA over a consecutive 6-month period. Consecutive patients will be included, and data will be collected from medical records until discharge, death or 30 days postoperatively, whichever is sooner. The primary outcome is in-hospital or 30-day mortality. Secondary outcomes include the aetiology of amputations and in-hospital complications. We will also examine systems and processes using a facility survey of each participating centre. The study will collect system-level, patient-level and outcome-level data. Our sample size calculation suggests 904 patients need to be recruited.
The RAMPs study will provide a snapshot of the current outcomes and aetiology of major lower limb amputation in SSA. It will show if variation in outcomes and aetiology in patients in the region exists and provide information on the healthcare processes and systems in those who may be at risk of lower limb amputation. Ethical approval has been granted by the University of Birmingham (Science, Technology, Engineering and Mathematics Committee reference: ERN_2929-Jan2025) and the College of Surgeons of East, Central and Southern Africa (COSECSA Institutional review board reference COSECSA/REC/2025/07). Findings will be disseminated throughout the region at local, national and international conferences and through at least one peer-reviewed manuscript.
Advancing equity, diversity and inclusion in health research trials is essential for improving health outcomes among priority populations. While evidence increasingly highlights the importance of cultural diversity in research trial leadership and participation, evidence-based strategies for enhancing this remain limited. This article outlines approaches to strengthen Aboriginal and Torres Strait Islander involvement in health research trials, drawing on insights from community engagement at the Darwin (Northern Territory) trial site of the Australian Fans in Training (Aussie-FIT) project.
Community engagement at this site aimed to (1) build mutually beneficial relationships with community leaders, specifically Aboriginal and Torres Strait Islander men; (2) codesign engagement standards to enhance the quality of engagement with these leaders and more broadly with local community members and stakeholders. A culturally diverse community advisory group was established, which codesigned engagement standards tailored to community needs and preferences.
While the codesigned standards supported Aboriginal and Torres Strait Islander trial leadership and participation during the trial, the extensive consultation needed to build cross-cultural relationships and develop the standards meant they were finalised only after trial recruitment had ceased. As a result, researchers were unable to fully implement them in the early stages of the trial.
This paper shared and critically discussed approaches used in the early stages of the Aussie-FIT trial to foster more equitable and inclusive practices in research trials. Implementation of these approaches and community-informed recommendations has the potential to enhance research quality, build trust with priority populations and address participation inequities, thus supporting effective trial design and improved health outcomes.
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).
by Stephen Mensah Arhin, Kwesi Boadu Mensah, Isaac Tabiri Henneh, Felix Yirdong, Evans Kofi Agbeno, Charles Ansah, Martins Ekor
BackgroundPsychological distress and social burdens associated with infertility among couples have been well-documented. However, little is known about the specific coping strategies employed by couples in low-middle-income countries such as Ghana, in the aftermath of unsuccessful infertility treatment attempts. In this qualitative study, we explored specific coping strategies patients adopt to address psychological distress related to unsuccessful treatment for infertility.
MethodsA semi-structured interview approach was used to elicit qualitative responses from 18 fertility clients after unsuccessful treatment at four fertility clinics in Ghana. Thematic analysis (TA) was used to examine the coping strategies adopted by participants in response to psychological distress associated with infertility treatment failures. This allowed us to explore potential culturally specific coping strategies employed by participants in response to infertility-related psychological distress.
ResultsThe themes that emerged as coping strategies in response to infertility-related psychological distress were diversional activities, intrapersonal cognitive reframing, social isolation, familial support, religious coping, avoidance-focused coping strategies, seeking encouragement, and professional help.
ConclusionThe findings from this study indicate that coping strategies that involve isolating oneself may not provide lasting emotional relief for individuals experiencing infertility. Relational activities contribute positively to coping. This is relevant in helping health professionals in the management of infertility treatment failures, which may include setting up support groups of similar experiences to draw strength from each. Furthermore, the results underscore the need to integrate psychological interventions into the counseling of couples following an unsuccessful infertility treatment. The clinical and research implications of these findings are discussed.
Using a 6-week porcine full-thickness excisional wound grafting model, we evaluated the Autologous Regeneration of Tissue (ART®) System, a novel skin harvesting device designed to collect autologous full-thickness autologous microcolumns (FTAM) at 0.5 mm in diameter. The donor skin sites were harvested using the ART® System and compared to split-thickness skin grafts (STSGs). Recipient sites were divided into three treatment groups: FTAM, STSG and Untreated control. Comparing the FTAM donor sites to the STSG donor sites, we observed significantly faster re-epithelization by Day 4 (p < 0.05), earlier adnexal structures and rete ridge formation by Week 3, and increased collagen and elastin content by Week 6. We also observed an increased rate of healing at the FTAM donor site whilst limiting donor site morbidity compared to traditional STSG donor sites. Time to recipient site closure was 2.4 weeks for STSG treated, 3.3 weeks for FTAM treated and 4.1 weeks for the Untreated control (p < 0.05). The STSG and FTAM recipient sites reached complete re-epithelialization by Weeks 4 and 5, respectively which was significantly faster compared to the Untreated control. However, the FTAM recipient site received only 10% of the donor site tissue relative to the recipient site area and the amount of donor site tissue grafted on the STSG recipient sites was 5× more than the FTAM recipient sites. Additionally, the FTAMs harvested by the ART® System augmented recipient wound site healing as a result of ‘epithelial island’ expansion in contrast to Untreated control sites that closed primarily by contracture.
by Siting Chen, Corey L. Nagel, Ruotong Liu, Anda Botoseneanu, Heather G. Allore, Jason T. Newsom, Stephen Thielke, Jeffrey Kaye, Ana R. Quiñones
IntroductionMultimorbidity may confer higher risk for cognitive decline than any single constituent disease. This study aims to identify distinct trajectories of cognitive impairment probability among middle-aged and older adults, and to assess the effect of changes in mental-somatic multimorbidity on these distinct trajectories.
MethodsData from the Health and Retirement Study (1998–2016) were employed to estimate group-based trajectory models identifying distinct trajectories of cognitive impairment probability. Four time-varying mental-somatic multimorbidity combinations (somatic, stroke, depressive, stroke and depressive) were examined for their association with observed trajectories of cognitive impairment probability with age. Multinomial logistic regression analysis was conducted to quantify the association of sociodemographic and health-related factors with trajectory group membership.
ResultsRespondents (N = 20,070) had a mean age of 61.0 years (SD = 8.7) at baseline. Three distinct cognitive trajectories were identified using group-based trajectory modelling: (1) Low risk with late-life increase (62.6%), (2) Low initial risk with rapid increase (25.7%), and (3) High risk (11.7%). For adults following along Low risk with late-life increase, the odds of cognitive impairment for stroke and depressive multimorbidity (OR:3.92, 95%CI:2.91,5.28) were nearly two times higher than either stroke multimorbidity (OR:2.06, 95%CI:1.75,2.43) or depressive multimorbidity (OR:2.03, 95%CI:1.71,2.41). The odds of cognitive impairment for stroke and depressive multimorbidity in Low initial risk with rapid increase or High risk (OR:4.31, 95%CI:3.50,5.31; OR:3.43, 95%CI:2.07,5.66, respectively) were moderately higher than stroke multimorbidity (OR:2.71, 95%CI:2.35, 3.13; OR: 3.23, 95%CI:2.16, 4.81, respectively). In the multinomial logistic regression model, non-Hispanic Black and Hispanic respondents had higher odds of being in Low initial risk with rapid increase and High risk relative to non-Hispanic White adults.
ConclusionsThese findings show that depressive and stroke multimorbidity combinations have the greatest association with rapid cognitive declines and their prevention may postpone these declines, especially in socially disadvantaged and minoritized groups.
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.
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