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Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial

INTRODUCTION: Critical limb ischemia (CLI) is a severe condition characterized by inadequate blood flow to the lower extremities, often leading to tissue damage and amputation. CLI is characterized by microcirculatory dysfunction, muscle tissue necrosis, and inflammation. Patients may suffer from th...

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Autores principales: Fu, Yan, Pu, Hongji, Huang, Qun, Qiu, Peng, Zhao, Deyin, Cheng, Yong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644844/
https://www.ncbi.nlm.nih.gov/pubmed/38021061
http://dx.doi.org/10.2147/IJGM.S429768
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author Fu, Yan
Pu, Hongji
Huang, Qun
Qiu, Peng
Zhao, Deyin
Cheng, Yong
author_facet Fu, Yan
Pu, Hongji
Huang, Qun
Qiu, Peng
Zhao, Deyin
Cheng, Yong
author_sort Fu, Yan
collection PubMed
description INTRODUCTION: Critical limb ischemia (CLI) is a severe condition characterized by inadequate blood flow to the lower extremities, often leading to tissue damage and amputation. CLI is characterized by microcirculatory dysfunction, muscle tissue necrosis, and inflammation. Patients may suffer from the traumatic pain and the increase of plantar pressure, and foot care for patients with CLI has become the “last mile” to improve their life quality. Traditional shoe insoles often lack individual customization, failing to address the unique anatomical needs and hemodynamic characteristics of patients. The study aims to investigate the effects of this innovative intervention on improving the clinical outcomes, and quality of life in CLI patients. METHODS AND ANALYSIS: This Critical Limb Ischemia Hemodynamic Insole Study is a randomized controlled study performed to explore the effect of a 3D printing insole on foot care of CLI patients. This study recruitment began on November 1, 2021. Patients with CLI confirmed by clinical symptoms and imaging were recruited as the research objects. Participants will be randomly assigned to either the experimental group, which will receive 3D-printed insoles customized based on their hemodynamics, or the control group, which will receive traditionally manufactured insoles. Both groups were followed up for up to 24 months after surgery, including claudication distance, claudication time, pain score, rehospitalization, etc. TRIAL REGISTRATION NUMBER: ChiCTR2100051857.
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spelling pubmed-106448442023-11-10 Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial Fu, Yan Pu, Hongji Huang, Qun Qiu, Peng Zhao, Deyin Cheng, Yong Int J Gen Med Study Protocol INTRODUCTION: Critical limb ischemia (CLI) is a severe condition characterized by inadequate blood flow to the lower extremities, often leading to tissue damage and amputation. CLI is characterized by microcirculatory dysfunction, muscle tissue necrosis, and inflammation. Patients may suffer from the traumatic pain and the increase of plantar pressure, and foot care for patients with CLI has become the “last mile” to improve their life quality. Traditional shoe insoles often lack individual customization, failing to address the unique anatomical needs and hemodynamic characteristics of patients. The study aims to investigate the effects of this innovative intervention on improving the clinical outcomes, and quality of life in CLI patients. METHODS AND ANALYSIS: This Critical Limb Ischemia Hemodynamic Insole Study is a randomized controlled study performed to explore the effect of a 3D printing insole on foot care of CLI patients. This study recruitment began on November 1, 2021. Patients with CLI confirmed by clinical symptoms and imaging were recruited as the research objects. Participants will be randomly assigned to either the experimental group, which will receive 3D-printed insoles customized based on their hemodynamics, or the control group, which will receive traditionally manufactured insoles. Both groups were followed up for up to 24 months after surgery, including claudication distance, claudication time, pain score, rehospitalization, etc. TRIAL REGISTRATION NUMBER: ChiCTR2100051857. Dove 2023-11-10 /pmc/articles/PMC10644844/ /pubmed/38021061 http://dx.doi.org/10.2147/IJGM.S429768 Text en © 2023 Fu et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Study Protocol
Fu, Yan
Pu, Hongji
Huang, Qun
Qiu, Peng
Zhao, Deyin
Cheng, Yong
Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title_full Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title_fullStr Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title_full_unstemmed Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title_short Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a Randomized Clinical Trial
title_sort application of 3d printing insole by hemodynamics in older patients with critical limb ischemia: protocol for a randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644844/
https://www.ncbi.nlm.nih.gov/pubmed/38021061
http://dx.doi.org/10.2147/IJGM.S429768
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