Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study

Launched by ISTITUTO NAZIONALE ASSICURAZIONE CONTRO GLI INFORTUNI SUL LAVORO · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of 3D printed prosthetic foot called PROFIL, which aims to help people who have had a below-knee amputation. The prosthetic is designed to mimic natural movement and make it easier for users to walk and engage in daily activities, even those that require more physical effort. The researchers want to understand how safe this prosthetic is and how well it performs during different activities like walking on flat surfaces or going up and down ramps and steps.

To participate, individuals must be between 18 and 65 years old, have a single below-knee amputation, and be able to move at a moderate to high level. Participants should weigh no more than 100 kg and have a stable condition with their amputation site. Those who are pregnant or have difficulty understanding instructions may not be eligible. If you join the study, you can expect to wear the prosthetic and help researchers gather important information about its comfort, safety, and performance in real-life situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Monolateral below knee amputation
• • Mobility level: K3 or K4
• • Age: 18-65 years old
• • Maximum weigth: 100 Kg
• • Collaborative subject
• • Clinically stable stump
• Exclusion Criteria:
• • Pregnant
• • Not able to understand written and oral instructions
• • Problems to the stump