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

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0
Tipo de produção
article
Data de publicação
2024
DOI
Scopus
Web of Science
PubMed
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ISSN da Revista
Título do Volume
Editora
ELSEVIER INC
Autores
GAMBA, Monica
Citação
CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, v.37, article ID 101247, 9p, 2024
Projetos de Pesquisa
Unidades Organizacionais
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Resumo
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.
Palavras-chave
Diabetes mellitus, Diabetic neuropathies, Diabetic foot, Plantar pressure, Digital orthosis
URI
https://observatorio.fm.usp.br/handle/OPI/58865
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MFT