The evidence identified suggest that Accel-Heal® may be an effective adjunct treatment for managing patients with non-healing venous leg ulcers (VLUs) and those who are unable to use standard treatment. There were improvements in the number of healed VLUs, mean healing times, exudate, pain scores and area of healing observed due to the treatment group.
The results of two small, local evaluations in NHS Greater Glasgow & Clyde and NHS Borders suggest that Accel-Heal® is associated with improved wound healing and a reduction in pain for individuals with non-healing VLUs.
The health economic evidence, although based on limited and generally low quality clinical evidence, suggests that Accel-Heal® could be a cost-effective treatment with the potential to realise savings through a reduction in dressings and nurse visits and improve patient quality of life.
Large, well-designed randomised controlled trials assessing relevant clinical, safety, cost and patient outcomes for longer periods are needed.
What were we asked to look at?
We were asked to provide a high level overview of Accel-Heal®.
Accel-Heal® is a non-sterile, single-use micro-current stimulation device intended to reduce inflammation, pain and exudate, and stimulate healing in wounds that are not progressing satisfactorily. Accel-Heal® is a small (7cm x 4cm x 2cm), disposable class IIA portable device that consists of electrode pads and six 48-hour, single-use, electrical energy units - applied consecutively to the pads to provide 12 days of treatment.
The device delivers a targeted, sub-sensory and precise dose of pulsed electrical energy through the electrode pads, which are applied to healthy skin on either side of the wound edge. The electrical energy aims to modify specific functions in the dermal tissue to improve and accelerate healing. The one-off treatment does not heal the leg ulcer during the 12-day treatment period but may initiate the wound healing physiological process.
Why is this important?
The precise prevalence of VLU in the United Kingdom (UK) is currently unclear. VLUs have a high reoccurrence rate (between 26% and 69%), unless the underlying cause is addressed.
The gold standard treatment for VLUs involves the use of high graduated compression (stockings, bandages or garments) to improve blood flow in the legs. However, standard wound management is not always effective. Some wounds may heal after longer periods, while a few may never heal. Furthermore, due to pain, persistent infections and lifestyle choices, some patients are not able to use compression therapy.
Synapse Electroceutical Limited, manufacturer of the device