LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees

Part of paid clinical trials in La Jolla, California.

Sponsor
LIMBER Prosthetics & Orthotics Inc
Study ID
NCT06648798
Status
Recruiting
Apply to this trial

Conditions

  • Amputation of Lower Limb
  • Non-inferiority Trial of Prothesis
  • Prosthesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Limber Limb — DEVICE
    Participants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).

Study Details

The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).

Key Dates

Start date
Dec 20, 2023
Status verified
Nov 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Intervention
    Participants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).

Primary Outcome Measure

Mobility - 6min walk [ Time Frame: Baseline, 4weeks, 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
David R Wing, MS
[email protected]
858-534-9315
Michael Higgins, MS
[email protected]
8585349315
Falko Kuester, Ph.D (PRINCIPAL_INVESTIGATOR)
Limber Prosthetics & Orthotics IncSan DiegoCalifornia92111
Luca De Vivo, PhD
[email protected]
310-602-9091
Herb Barrack, CPO
[email protected]
(310) 602-9091
Herb Barrack, CPO (PRINCIPAL_INVESTIGATOR)
Luca De Vivo, PhD (SUB_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CALimber Prosthetics & Orthotics Inc· San Diego, CA

Related Studies