Diabetic neuropathy device to be trialled
A non-invasive device designed to help reduce pain associated with diabetic peripheral neuropathy (DPN) is to be trialled in the UK.
The Aptiva® system uses frequency rhythmic electrical modulation system (FREMS) to alleviate pain in DPN sufferers.
Research into the system will be carried out on the at a leading diabetes centre in Birmingham, before it will be taken forward to the National Institute for Health and Care Excellence (NICE) for approval.
The system is already being used in diabetes and neurological clinics in Italy, the Netherlands, Belgium and Canada.
Bharat Vadukul, business director of BHR Pharmaceuticals Ltd, the company behind the UK launch of Aptiva, said: “We are delighted to be bringing Aptiva to the UK. As the research shows, the device can provide a helpful addition to the treatment already available for pain management of DPN, with no significant side effects.”
A total of 80 people took part in an independent randomised study in Italy. Their neuropathy symptoms ranged from mild to severe.
The findings showed there was a “significant decrease” of pain among the people who underwent the treatment.
Symptoms can range from mild tingling and aching to chronic severe pain described as stabbing or burning, like an electric shock.
As well as pain, DPN is the primary cause of diabetic foot ulcerations, which in turn are the major cause of lower limb diabetic amputations.
The only side effects the Aptiva has shown so far is mild burning sensations at the site of the electrode pads which wore off when the treatment session ended.