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Application of 3D Printing Insole by Hemodynamics in Older Patients with Critical Limb Ischemia: Protocol for a
Yan Fu1, Hongji Pu2, Qun Huang2
1Department of Nursing, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Insights
Custom 3D-printed insoles show promise for improving foot care in critical limb ischemia (CLI) patients. This innovative approach may enhance clinical outcomes and quality of life for individuals with this severe circulatory condition.
Area of Science:
- Vascular Surgery
- Biomedical Engineering
- Podiatry
Background:
- Critical limb ischemia (CLI) severely impacts lower extremity blood flow, causing tissue damage and amputation risk.
- Microcirculatory dysfunction, necrosis, and inflammation characterize CLI, leading to pain and increased plantar pressure.
- Traditional insoles lack customization, failing to meet the specific needs of CLI patients.
Purpose of the Study:
- To evaluate the efficacy of custom 3D-printed insoles for critical limb ischemia (CLI) patient foot care.
- To investigate the impact of hemodynamic-based customized insoles on clinical outcomes and quality of life in CLI patients.
Main Methods:
- A randomized controlled trial comparing 3D-printed insoles with traditional insoles.
- Recruitment of CLI patients confirmed by clinical symptoms and imaging, starting November 1, 2021.
- Follow-up for up to 24 months, assessing claudication distance, time, pain scores, and rehospitalization rates.
Main Results:
- The study is ongoing, and results are pending.
- The primary outcome measures include improvements in claudication distance, pain reduction, and decreased rehospitalization.
- Secondary outcome measures focus on enhanced quality of life for CLI patients.
Conclusions:
- Customized 3D-printed insoles represent a novel therapeutic strategy for critical limb ischemia.
- This intervention has the potential to significantly improve patient quality of life and reduce amputation rates.
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.
