The effects of the use of customized silicone digital orthoses on pre-ulcerative lesions and plantar pressure during walking in people with diabetic neuropathy: A study protocol for a randomized controlled trial

People with diabetes and diabetic peripheral neuropathy (DPN) often develop calluses due to toe misalignment and increased plantar pressure. Untreated, these issues can progress into ulcers, making early intervention crucial. This trial protocol aims to evaluate the efficacy and safety of customized silicone digital orthoses in preventing ulcers, pre-ulcerative lesions, and peak pressure during gait in people with DPN.