An electrical stimulation device created by scientists at NUI Galway to heal venous leg ulcers has gone to the patient evaluation stage.
Developed by the Bioelectronics Research Cluster at the National Centre for Biomedical Engineering Science (NCBES) at NUI Galway, the wearable device causes artificial calf muscle pump action.
It is hoped the electrical stimulation device will prove more successful in combating these painful ulcers and preventing their return than conventional bandaging techniques.
Approximately 70 per cent of all leg ulcers are venous ulcers. Most venous leg ulcers occur because the valves connecting the superficial and deep veins are not functioning properly.
Prof Gearóid Ó Laighin, Bioelectronics Research Cluster leader at the NCBES, NUIG said older people are particularly susceptible to venous leg ulcers if they have been immobilised for a sustained period.
They also commonly affect coma patients and those in long-term physical rehabilitation.
"When you walk and your calf muscle contracts, it squeezes blood up and the valves stop the blood going back. If you are sedentary or immobilised, you will not get the benefit of this calf muscle pump and you can get pooling of venous blood which can coagulate.
"This can damage the valves and cause venous hypertension. The pressure pushes material into the tissue which is what causes the ulcer," he explained.
The device designed at NUIG is an artificial calf muscle stimulator which uses electrodes to stimulate the muscle and works even if the patient is immobilised.
The researchers are currently working on making the device more compact and comfortable for patient use.
Much of the design work has been carried out by Dr Paul Breen, a postdoctoral researcher at the Bioelectronics Research Cluster.
The device has been independently tested by TUV Labs in Germany and Prof Ó Laighin's team now has ethical approval to start using it on patients. They will begin recruiting patients over the next six months.
"Conventional techniques use compression bandaging which needs to be fitted on a weekly basis by a nurse and is worn from hip to toe. After 12 weeks of treatment, this technique will typically have only healed 50 per cent of patients and even then, there is a risk the problem will recur," said Prof Ó Laighin.
The clinical collaborator on the project is Prof Pierce Grace, vascular surgeon at Midwest Regional Hospital, Limerick.
The team began using electrical muscle stimulators with "real time capability" for rehabilitation purposes, such as gait restoration after stroke.
They decided to apply the same principle to the treatment of venous leg ulcers.
Ó Laighin said: "We have already got some very positive data from applying electrical stimulus to patients. We felt the results merited moving onto the next stage and using the technique as a treatment for venous leg ulcers."
The Bioelectronic Research Cluster team are also developing a range of wearable electronics for health management which monitor a person's health status and transmit information to their healthcare providers.
"It is generally expected that a significantly increased use of electronic and other technologies will be required to provide an efficient healthcare delivery system in the face of ongoing demographic change," Ó Laighin adds.
He says it is estimated that by 2035, around 33 per cent of the EU's population will be over 65 and healthcare delivery methods will need to be adapted to meet the challenges posed by these changing demographics, while constrained by limited resources.
