A groundbreaking clinical trial led by researchers at the University of Galway is set to transform the treatment of a chronic and debilitating vein condition. Forty patients with venous leg ulcers (VLUs ) are being enrolled in the trial in Ireland, which is coordinated through the University’s Institute for Clinical Trials, enabling clinicians to monitor and direct treatment remotely in real time.
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 with 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 the 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 patients' healing rates, quality of life, and how the FeelTect Tight Alright™ device is used and the compression treatment is applied.
The trial is enabling remote monitoring and data collection, either at home or at 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 the University of Galway through its Trials Accelerator programme, which provides early-phase setup support.
Patients are recruited through the 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 the University of Galway, which is responsible for the operational and clinical execution of the trial.
