A ground-breaking 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 co-ordinated 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 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.
Prof 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-centered 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.”
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.
