ANZCTR search results

Achilles tendinopathy can cause persistent pain and reduced ability to tolerate activities that load the tendon. This study will investigate whether ankle position changes the immediate response of the Achilles tendon and calf muscle to isometric loading in healthy adults and adults with mid-portion Achilles tendinopathy. Each participant will complete two laboratory sessions in a randomised order, with loading performed in either a neutral ankle position or 25° of plantarflexion. Ultrasound, force and muscle-activity measurements will be collected before, during and after loading to assess tendon stiffness, volume and deformation, as well as calf muscle structure. Pain, acceptability, fatigue and symptoms approximately 24 hours after testing will also be recorded to help inform future research on Achilles tendon loading and rehabilitation.

Actinic keratoses (AKs) and intraepidermal carcinomas (IECs) are common precursors to cutaneous squamous cell carcinoma (non-melanoma skin cancers). This study aims to assess the feasibility, acceptability, safety and preliminary clinical activity of two doses of 5-fluorouracil (5FU) and calcipotriol treatments. Who is it for? You may be eligible for this study if you are aged 18 to 85 years, you have been diagnosed with either actinic keratoses or intraepidermal carcinomas on your face and you are willing to attend multiple study appointments. Study details Participants who choose to enrol in this study will be asked to apply each of the two treatments to opposite sides of their face twice a day for up to 6 days. The specific treatment to be applied to each side of the face will be determined randomly, by chance (similar to flipping a coin). Before and after applying the treatments, participants will be asked to have clinical photos taken of their face and will be asked to complete a series of questionnaires for up to 2 years after the treatment period. It is hoped this research will determine that the combination of 5-fluorouracil (5FU) and calcipotriol treatments is safe and acceptable to people with actinic keratoses or intraepidermal carcinomas. If this study is successful, a larger trial enrolling more people with actinic keratoses or intraepidermal carcinomas may be undertaken to determine the most effective dose combination of these treatments.

People who take insulin for diabetes can have their glucose fall too low, and if this happens while they are driving it can affect concentration and reaction time. Most now wear a continuous glucose monitor that sends readings to their phone, and since 2023 Victorian road rules have allowed drivers to view a securely mounted display showing information about their own condition, but nobody has tested whether having that reading visible actually makes a difference on real roads. In this study, Victorian drivers with insulin-treated diabetes each take part for two months: for one month, chosen at random, they drive with their phone in a dashboard mount so their glucose is visible at a glance, and for the other they drive as they normally would without it. A small GPS logger in the car records when they were driving, so their glucose readings can be matched to the times they were actually behind the wheel and each person can be compared with themselves. We want to find out whether the visible reading keeps glucose in a safer range while driving, whether it reduces time spent low at the wheel, and what drivers themselves think of it, so that better advice can be given to drivers with diabetes and to those who set road safety policy.

Upper limb injuries, including broken bones and dislocations, often need to be physically realigned in the emergency department (ED). This is painful, so clinicians use various techniques to manage pain during the procedure. The most common approach is procedural sedation (PS), where participants receive medication through a drip that makes them sleepy or unconscious. While effective, this approach requires close monitoring, dedicated staff, and a recovery period before leaving the ED. It also carries risks such as breathing problems and low blood pressure. An emerging technique in ED is ultrasound-guided supraclavicular block (UGSCB), which involves using ultrasound to guide an injection of numbing medication near the nerves above the collar bone. This numbs the injured arm without the need for sedation, allowing the participant to remain awake. Our recent research showed that this technique was an effective form of regional pain relief for managing broken wrists. However, no study has compared it to PS, which anecdotally is often preferred by emergency physicians across Australia and New Zealand. This project is a clinical trial across four ED’s that will randomly assign participants to receive either UGSCB or PS. The main measure will be reported pain levels, with additional measures including participant satisfaction, safety, time spent in ED and painkiller use. We expect the nerve block will provide equally effective and safe pain relief while allowing participants to leave the ED sooner, which could help participants and their families and reduce pressure on busy emergency departments.

The VXM-301-001 study is a Phase I multi-centre clinical study to evaluate the safety and tolerability of VXM-301 typhoid conjugate vaccine delivered using HD-MAP, in healthy adults aged 18 to 45 years. The study design enables the evaluation of local reactogenicity and systemic toxicity events related to the in administration of TCV HD-MAPs in healthy adults at lower or equivalent doses than the standard adult IM dose. In addition, the VXM-301-001 study allows exploratory data collection on preliminary immunogenicity of TCV delivered using HD-MAP.

The aim of this project is to evaluate the effectiveness and implementation of CycLink across 4 regions in Victoria (Ballarat, Geelong, Inner South-East Metro Melbourne and Outer South-East Metro Melbourne). CycLink has been co-designed to link young people with disability and developmental differences to participation in cycling in their local communities. This project involves a hybrid effectiveness-implementation trial, including program and process evaluation of CycLink and an evaluation of the process of adapting the program to context (where CycLink is being delivered) through codesign. Our primary aim is to determine whether CycLink (goal setting, information + cycling program) is more effective for attainment of cycling participation goals than goal setting and information alone in young people aged 5-17 with disability and/or developmental differences.

Researchers are investigating how different types of dietary fats affect the way the body processes fats and a protein called amyloid-beta (Aß), which is linked to Alzheimer’s disease. The study will also look at whether these effects differ between people with different APOE genes, specifically APOE e3 and APOE e4. Participants will eat three different meals containing either saturated fat, unsaturated fat, or no added fat on separate days, with blood samples collected before and up to 8 hours after each meal. Based on previous research, the researchers expect that meals high in saturated fat may cause a greater increase in Aß in the blood compared with unsaturated fat. The study will help determine whether dietary fat and APOE type affect how Aß is produced, transported in the blood, and processed by the body after eating.

This study aims to determine whether adding cryo-cuff therapy (a device combining cold application with intermittent pneumatic compression) to standard post-operative care reduces opioid use after arthroscopic rotator cuff repair (aRCR) surgery. Rotator cuff repair is common and often very painful afterwards, usually requiring opioid pain medication. Opioids carry risks including nausea, sedation, dependence and misuse, and these risks can be harder to manage in regional and rural areas where follow-up care is less accessible. Cryo-cuff therapy is a low-cost, low-risk option already used in some clinical practice, but there is not yet good-quality evidence specific to rotator cuff repair to show whether it actually reduces opioid use. This randomised controlled trial will compare opioid consumption in the first 14 days after surgery between patients who use a cryo-cuff device alongside standard care and patients who receive standard care alone. Post-operative pain will be tracked during the first week, patient satisfaction with recovery will be assessed over the first 6 weeks, and shoulder function and return to work will be followed for up to 3 months. Findings will help clarify whether cryo-cuff therapy should be adopted as standard post-operative care, particularly in regional settings where minimising opioid use and supporting recovery with limited follow-up access is especially important.

This study aims to evaluate a new, accessible treatment program designed to help children aged 3 to 12 years overcome specific phobias (such as fears of animals, the dark, or storms). The program, called FAST-CBT, trains parents to support their child in gradually facing fears using evidence-based strategies from cognitive behaviour therapy (CBT), particularly exposure therapy. Families will be randomly allocated to either begin the program immediately or continue with their usual care for 8 weeks before receiving the program. The study will examine whether children whose parents receive FAST-CBT show greater improvements in their fears, daily functioning, and overall wellbeing compared to those receiving usual care. We expect that children in the FAST-CBT group will be more likely to overcome their phobia and show greater improvements in functioning than those in the usual care group.

TOPAS is a parallel 1:1 randomised controlled trial (n=256) that will determine whether adding topical diclofenac gel to self-care advice with a heat pack reduces back and neck pain intensity more than providing self-care advice with a heat pack alone across the first 3 days after initiating treatment in patients with an acute episode of back or neck pain or an acute flare of chronic low back or neck pain. Secondarily, we aim to compare other clinical (e.g. disability, quality of life, use of other pain medicines) and safety outcomes between trial arms.