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

Description

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).

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Amputation of Lower Limb
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

San Diego

Limber Prosthetics & Orthotics Inc, San Diego, California, United States, 92111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form.
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 3. Persons, aged 18 to 75
  • 4. In good general health as determined by clinical site monitor
  • 5. Weight \< 125kg
  • 6. Are not diabetic (self reported)
  • 7. Be a unilateral transtibial amputee of more than 1 year since amputation
  • 8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
  • 9. Live in the Southern California region (within 50 miles of UCSD)
  • 10. Has sufficient sensation in residual limb as tested by the clinical site monitor
  • 11. Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)
  • 1. Not currently using a prosthetic device
  • 2. Prosthetic device with active motors, sensors, etc.
  • 3. Pregnancy (due to fall risk)
  • 4. Diabetic (due to poor limb sensation), self reported
  • 5. No under 18 (due to inability to consent)
  • 6. No over 75 (due to fall risk)
  • 7. Poor proprioception or sensation at the residual limb

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LIMBER Prosthetics & Orthotics Inc,

Herb Barrack, CPO, PRINCIPAL_INVESTIGATOR, LIMBER Prosthetics & Orthotics Inc

Study Record Dates

2026-10-31