Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial.

Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out.

Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders.

ISRCTN15570706.

Glycated haemoglobin A1c (HbA1c) measurement is essential for managing diabetes, yet limited data exist on the performance of point-of-care (POC) HbA1c devices in low- and middle-income countries (LMICs). This study evaluated the analytical performance and usability of HbA1c devices in different LMIC settings.

This prospective, cross-sectional multicentre study evaluated the accuracy and usability of four POC devices (i-SENS A1Care, HemoCue HbA1c 501 System, Abbott Afinion 2 and Siemens DCA Vantage) against a laboratory-based HbA1c method at two hospitals in Nigeria and Cambodia.

Adults with or without diabetes and haemoglobin ≥8 g/dL were enrolled.

The primary objective was to evaluate HbA1c POC device accuracy versus laboratory reference testing; secondary objectives evaluated device usability and technical characteristics when used by trained professionals.

Capillary and venous blood samples were tested on all devices using two cartridge lots followed by reference testing. Usability was assessed via operator questionnaires. Accuracy was evaluated using regression slopes, intercept, absolute bias at 30, 48 and 75 mmol/mol, and Bland-Altman analysis, including capillary-venous concordance.

A total of 248 participants completed all study procedures (n=125 in Cambodia, n=123 in Nigeria). Siemens DCA Vantage and Abbott Afinion 2 showed strong agreement with the reference method, with no clinically significant differences and narrow limits of agreement. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System displayed greater bias, especially at elevated HbA1c levels. Most results fell within limits of agreement, though high-HbA1c outliers were more common with the A1Care and HbA1c 501 System devices. Usability feedback was positive overall, when devices were rated across various dimensions, such as clarity of instructions, safety and labelling, although limited user sample size constrains the generalisability of these findings.

Siemens DCA Vantage and Abbott Afinion 2 demonstrated reliable accuracy and usability. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System require cautious interpretation at high HbA1c levels. Ongoing evaluation is critical to ensure the appropriate use of POC devices in diverse clinical settings.

NCT06170515.

Scabies is a common skin condition and poses a substantial disease burden in resource-poor tropical settings. The Rohingya refugee camps in Cox’s Bazar, Bangladesh represent one of the world’s largest and most protracted humanitarian crises. Using 3 years of data from 2021 to 2023, this study analysed the seasonality of scabies and examined its association with climatic factors.

This is a retrospective observational study conducted in the Rohingya refugee camps and adjacent host communities in Ukhiya and Teknaf, Cox’s Bazar. All patients clinically diagnosed with scabies and who received treatment at 35 International Organization for Migration (IOM)-supported health facilities between 1 January 2021 and 31 December 2023 were included. Climate data, including daily mean, minimum and maximum temperature and total and maximum rainfall, were obtained from the Bangladesh Meteorological Department. Seasonal–Trend decomposition using LOESS (locally estimated scatterplot smoothing) (STL) was applied. Associations between climatic variables and the decomposed seasonal component of scabies cases and corresponding attack rate, as well as overall scabies case counts and overall attack rate, were assessed using Pearson’s correlation tests.

A total of 323 106 new scabies cases were reported from IOM-supported health facilities between January 2021 and December 2023. Children aged under 5 years and 6–18 years accounted for the highest proportion of cases (32.08% and 38.95%, respectively). The average monthly number of scabies cases was highest in November (12 625) and lowest in May (5862). Case numbers increased from November to February (high season), with a peak between October and November, and declined between April and June (low season). An inverse relationship was observed between temperature and scabies incidence, with higher case numbers during cooler months and lower numbers during warmer months. Pearson’s correlation analysis demonstrated a strong and significant negative correlation between the seasonal components of both scabies cases and attack rate and temperature variables, including maximum (cases: r=–0.492, p=0.002; attack rate: r=–0.484, p=0.003), minimum (cases: r=–0.506, p=0.002; attack rate: r=–0.489, p=0.002) and mean temperature (cases: r=–0.525, p=0.001; attack rate: r=–0.511, p=0.001). No significant association was observed between the seasonal component of scabies cases or attack rate and humidity or rainfall.

This study identified a distinct seasonal pattern of scabies, with higher caseloads and attack rate during late autumn and winter (October to February) and lower caseloads and attack rate during summer months (April to June). Temperature showed a strong negative association with the seasonal component of scabies burden. These findings may inform the timing of public health strategies, including mass drug administration, intensified case management and social and behavioural change communication, in humanitarian settings.

Adhesive capsulitis (frozen shoulder) is a common condition characterised by pain, stiffness and reduced function. While conventional physiotherapy (typically comprising joint mobilisation, stretching, strengthening and electrotherapy) is widely used, there is limited evidence for the effectiveness of advanced neuromuscular techniques such as the reciprocal inhibition technique (RIT). This study aims to evaluate the impact of incorporating RIT into standard physiotherapy compared with standard physiotherapy alone in individuals with adhesive capsulitis.

This is a double-blind, randomised controlled trial. 30 adults aged 30–70 years with clinically confirmed adhesive capsulitis will be recruited from a tertiary rehabilitation centre in Dhaka, Bangladesh. Participants will be randomly allocated to receive either RIT combined with conventional physiotherapy or conventional physiotherapy alone, with both groups undergoing 12 treatment sessions over 4 weeks. The primary outcome is pain intensity at 4 weeks post-randomisation, measured by the Numeric Pain Rating Scale. Secondary outcomes include shoulder range of motion (abduction, internal and external rotation, assessed with a universal goniometer), functional ability (Shoulder Pain and Disability Index) and muscle strength (abduction, internal and external rotation, measured by hand-held dynamometry). Blinded assessors will conduct evaluations at baseline and after the intervention. Data will be analysed using intention-to-treat principles. Between-group comparisons will be made using linear mixed models with fixed effects for group, time and group-by-time interaction, and a random intercept for participants to account for repeated measurements. Within-group changes will be estimated from the models.

This trial has received ethical clearance from the Institutional Review Board of the Institute of Physiotherapy, Rehabilitation & Research (approval number BPA-IPRR/IRB/18/02/2025/32). Results will be disseminated through peer-reviewed publications and international conferences in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. By addressing a significant evidence gap, this study may establish RIT as an effective and affordable adjunct to standard physiotherapy for managing adhesive capsulitis.

CTRI/2025/06/089288 [Registered on: 23/06/2025]

The main treatment of chronic subdural haematoma (CSDH) is neurosurgical evacuation with subsequent drainage. However, consensus on optimal drain modality and placement is lacking.

To examine whether 24-hour active subperiosteal drainage is non-inferior to 24-hour passive subdural drainage after a single burr hole evacuation of a symptomatic CSDH.

SUPERDURA is a multicentre randomised non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical haematoma evacuation, patients will be randomised to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score, 90-day serious adverse events and complications related to surgery or occurring during admission, including intracerebral haemorrhage due to misplaced drains, acute subdural haematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal haematoma, thromboembolic events, infections and seizures.

A detailed statistical analysis plan is published separately. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years.

Ethics approval for the inclusion of competent patients has been obtained from the North Denmark Region Committee on Health Research Ethics. Results of the primary and secondary outcomes will be submitted for publication in an international peer-reviewed journal and presented at relevant neurosurgical meetings.

N-20240009, accepted 13 May 2024 and 13 December 2024.

NCT06621407.

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth

The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.

NCT06122506.

The use of different electronic devices is increasing among students due to rapid advancements in digital technology. The prevalence of computer vision syndrome (CVS) has increased among school children after the COVID-19 pandemic. Different symptoms of CVS, such as eye strain, headache, blurred vision and visual discomfort, have become major public health problems. This study aimed to assess the prevalence of CVS, identify its risk factors, evaluate parental awareness and examine the impact of COVID-19 on screen time among primary school children in Dhaka, Bangladesh.

Primary data were collected from the parents of 500 primary school students aged 5–14 years using a convenience sampling method through face-to-face interviews. A structured questionnaire was administered to collect demographic information, screen usage patterns, ambient conditions and details regarding the children’s academic performance. The Computer Vision Syndrome Questionnaire scale was used to assess the prevalence and severity of CVS. Various statistical analyses were performed, including ² tests, Fisher’s exact tests and logistic regression, to identify significant predictors of CVS (p

Findings revealed that 16.4% of children were affected by CVS, with key risk factors including age, school year, maternal education and daily screen time. Children with CVS commonly reported headaches and itchy eyes, which negatively impacted their academic performance. Surprisingly, 67.4% of parents were unaware of CVS, and the odds of developing CVS were 3.74 times higher among children using electronic devices for more than 4 hours daily.

The study explored the low prevalence of CVS among primary school students in Dhaka, Bangladesh. Several symptoms, like headaches and eye discomfort, were identified that impaired their academic performance. Additionally, many parents were largely unaware of CVS. Therefore, it is necessary to take proper strategies to be aware of the consequences and lessen the prevalence of CVS to save our future generation.