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

Abstract

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.

Keywords:

• 3D printing
• insole
• hemodynamics
• critical limb ischemia

Ethics Approval and Informed Consent

The study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of Shanghai Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine (SH9H-2021-T233-2). This study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and the Guideline for Good Clinical Practice. Written informed consent will be obtained from each adult participant. Yong Cheng is the supervisor of this study. The interim and final results will be published in peer-reviewed journals.

Disclosure

The authors declare that they have no competing interests.

Additional information

Funding

This work is supported by the Clinical Research Program of 9th People’s Hospital (JYLJ202010), Shanghai Science and Technology Innovation Action Plan (20Y11909600), Biomedical Science and Technology Support Project (21S31904300), Shanghai Municipal Health Bureau Project (202040434), Shanghai Ninth People’s Hospital Nursing Fund Project (JYHL2020MS01, JYHL20213D07), Shanghai 3-year Action Plan – Disease Cohort Project (SHDC2020CR6016-003), and Translational Medicine Science and Technology Infrastructure Opening Project (TMSK-2021-121).