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.

ABSTRACT:

Background

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.

Methods

In this superiority randomized controlled parallel trial with single-blind assessment, 60 participants will be allocated to the control group (CG) or the intervention group (IG). The CG will receive specialized nurse-administered foot care, including callus removal, nail care guidance, and self-care education. The IG will receive the same ca

SUBMITTER: Lucoveis MLS 

PROVIDER: S-EPMC10806755 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature