New clinical trial to enable remote patient treatment and monitoring

Photo Dr Andrew Cameron, co-founder and Chief Executive of FeelTect, and Dr Darren Burke, co-founder and Chief Technology Officer of FeelTect. Credit – Andrew Downes, xposure.

A groundbreaking clinical trial led by researchers at University of Galway is set to transform how a chronic and debilitating vein condition is treated.

Forty patients who suffer from venous leg ulcers (VLUs) are being enrolled in the trial in Ireland, which is being coordinated through the University’s Institute for Clinical Trials, enabling clinicians to monitor and direct treatment remotely, in real-time.

Improving remote patient treatment and monitoring

The trial is being carried out in partnership with FeelTect, a medical technology start-up based in Spiddal, Co. Galway, as part of funding through the Government’s Disruptive Technology Innovation Fund, managed by the Department of Enterprise, Trade and Employment and administered through Enterprise Ireland.

Patients will be treated using advanced pressure monitoring technology. FeelTect has created a wearable, pressure-sensing device, Tight Alright®, which when paired with a mobile app, can enable clinicians to measure and remotely monitor sub-bandage pressure applied during compression therapy. This supports more consistent compression application with the potential to improve healing rates, reduce treatment costs and enhance patient quality of life.

Professor Fidelma Dunne, Director of the Institute for Clinical Trials, University of Galway, said: “This trial reflects the role of the Institute for Clinical Trials as a national centre of excellence in the design and delivery of innovative studies. By integrating decentralised, patient?centred approaches, we are strengthening Ireland’s clinical research capabilities and supporting the national objective to retain and grow trial activity. Through the Government’s DTIF support, this collaboration with an Irish start-up demonstrates how innovation developed in Ireland can be tested, validated and scaled within our own health system through academic-industry collaborative partnerships.”

Dr Andrew Cameron, Chief Executive of FeelTect, said: “We are delighted to see the commencement of this valuable research, assessing data-driven, connected-health solutions for improving the treatment of venous leg ulcer patients. FeelTect is extremely fortunate to be working with our valued partners in University of Galway, including the Institute for Clinical Trials and Clinical Trials Corrib Research Centre, as well as world class clinicians, ensuring the quality and successful execution of the study. The broader implications of the study relate to the optimisation of compression therapy – a fundamental, first-line treatment for a host of venous and lymphatic diseases.”

Over a 90-day period, the research team will assess healing rates of patients, their quality of life and how the FeelTect Tight Alright™ device is used and how the compression treatment is applied.

The trial is enabling remote monitoring and data collection – either at home or in local primary care centres. This reduces the need for frequent hospital visits, improves patient comfort and reduces unnecessary clinical visits – an approach which is particularly beneficial for patients with mobility challenges while also allowing clinicians to better understand treatment effectiveness outside a clinical facility.

The study is supported by the Institute for Clinical Trials at University of Galway through its Trials Accelerator programme, which provides early-phase setup support. Patients are recruited through Merlin Park Vascular Outpatients clinic, HSE West North West, and community centres in the region. Clinical delivery is being carried out by the CORRIB Core Lab at University of Galway which is responsible for the operational and clinical execution of the trial.

About the Institute for Clinical Trials

The Institute for Clinical Trials at University of Galway is a national centre of excellence for the design and delivery of cutting edge health tech research. By providing end to end trial expertise and partnering closely with industry and innovators, the Institute is strengthening Ireland’s capacity to run high quality clinical studies, and positioning the country as a competitive, go to location for clinical research in Europe and internationally.

About University of Galway

Established in 1845, University of Galway is one of the top 2% of universities in the world. We are a bilingual university, comprised of four colleges, 18 schools and six research institutes, with more than 19,700 students, including around 3,000 international students. We have been accredited with an Athena SWAN Institutional Silver Award, and 14 out of our 18 schools hold individual Athena SWAN Awards. We have more than 2,500 staff, and research collaborations with 5,300 international institutions in 181 countries. Our innovative academics and researchers have created 21 new spin-outs 195 new inventions since 2020. We have 135,000 alumni and 98% of graduates are in employment or further study within six months.

For more information visit https://www.universityofgalway.ie/ or view all news

Get the most from the expert commentary, views and stories from University of Galway on our Cois Coiribe platform https://impact.universityofgalway.ie/

See more breaking stories here.