ArticleContemporary clinical trials communications2024
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.
Article in Contemporary clinical trials communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05683106 (Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy: a Randomized Controlled Clinical Trial
Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
- Practical guidelines for the prevention and management of diabetic foot disease in China.Burns & trauma · 2025Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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).
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