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

Maria L S Lucoveis; Mônica Gamba; Erica Queiroz Silva; Letícia A S Pinto; Isabel C N Sacco

doi:10.1016/j.conctc.2023.101247

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

Contemp Clin Trials Commun. 2023 Dec 23:37:101247. doi: 10.1016/j.conctc.2023.101247. eCollection 2024 Feb.

Authors

Maria L S Lucoveis¹, Mônica Gamba², Erica Queiroz Silva¹, Letícia A S Pinto¹, Isabel C N Sacco¹

Affiliations

¹ School of Medicine, Physical Therapy, Speech and Occupational Therapy Dept., University of Sao Paulo, Sao Paulo, Brazil.
² Nursing School at Federal University of São Paulo, São Paulo, Brazil.

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 care plus a customized silicone orthosis for toe realignment for 6 months. Assessments will occur at baseline and 3 and 6 months for the primary outcomes (pre-ulcerative lesions and ulcer incidence) and secondary outcomes (pressure distribution, foot function and health, quality of life, safety, and comfort). Two-way ANOVAs (p < .05) will assess group, time, and group by time effects following an intention-to-treat approach.

Conclusion: Although recommended for foot ulcer prevention, custom silicone orthosis adoption remains limited due to the low certainty of evidence. This trial seeks to provide more consistent evidence for the use of toe orthoses in preventing callus and ulcer formation for individuals with DPN.

Trial registry: ClinicalTrials.gov (NCT05683106) "Effects of Customized Silicone Digital Orthoses in People with Diabetic Neuropathy" (registered on December 20, 2022).

Keywords: Diabetes mellitus; Diabetic foot; Diabetic neuropathies; Digital orthosis; Plantar pressure.

Associated data

ClinicalTrials.gov/NCT05683106