🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - 75 YearsAllLIMBER Prosthetics & Orthotics Inc
NCT06648798 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion 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.) Exclusion Criteria: 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
💊

What it tests

  • Limber Limb
📍

Where

2 sites
University of California San Diego
La Jolla, United States
Limber Prosthetics & Orthotics Inc
San Diego, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy