Safety evaluation of the DiaSole insole with diabetic foot ulcers

Neuropathy and ischaemia are two pathologies that develop in the feet of individuals who have diabetes type 1 or 2, both of which lead to foot ulceration. Peripheral nerves in the lower limbs are susceptible to different types of damage in individuals who have diabetes, due to hyperglycaemia (Edmonds et al., 2021). Up to approximately 34% of people with type 1 or 2 diabetes develop a diabetic foot ulcer (DFU) in their lifetime, about 20% of these will undergo a lower extremity amputation (LEA)to remove the foot as a result of infection and progressive gangrene (Armstrong et al., 2023). A further 20% of people with DFU require hospitalisation, of which 15% to 20% will also require LEA (Armstrong et al., 2023). The International Working Group on the Diabetic Foot (IWGDF) recommend that a nonremovable knee-high offloading device with an appropriate foot-device interface is the first choice of offloading treatment to promote the healing of ulcers (Munro et al., 2021). TriTech was commissioned by Kaydiar LTD. on 18/08/2022 to carry out a clinical investigation of DiaSole, which was setup as an ‘Extended Phase 2 Product Evaluation Single Sample Study’. This clinical trial began patient recruitment on the 30/06/2023 and concluded on the 30/09/2024.