3D printed customized prosthetic legs for amputees
Official title: LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Run by LIMBER Prosthetics & Orthotics Inc · NCT06648798 · Data updated 2026-11-12
This study is testing a new 3D printed prosthetic leg for amputees to see if it works as well as traditional ones while being cheaper and faster to make.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | LIMBER Prosthetics & Orthotics Inc Industry-sponsored |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Status | Recruiting |
| Started | December 20, 2023 |
| Main results expected | October 31, 2025 |
| Study ends | October 31, 2026 |
| Registry record updated | November 26, 2024 |
| Trial ID | NCT06648798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are unilateral transtibial amputees aged 18 to 75 who have been amputated for over a year and currently use a passive prosthetic device.
✕Probably not a fit
Patients who are diabetic or have significant health issues that could affect their participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The LIMBER UniLeg is a clinical trial evaluating a 3D printed single-piece transtibial prosthetic limb designed to be equivalent to traditional passive prosthetic limbs while significantly reducing manufacturing costs and time. This single-site study involves 30 participants who will use their existing prosthetic device for one month and the LIMBER UniLeg for another month, assessing its effectiveness and safety. The trial aims to address the global prosthetic accessibility crisis by leveraging digital technologies to create affordable and accessible solutions for amputees.
Why it matters
Potential benefit: If successful, this study could provide a more affordable and accessible prosthetic option for amputees, improving their quality of life.
How similar studies have gone: While other studies have explored 3D printed prosthetic sockets, this approach of a fully 3D printed unibody prosthesis is novel and has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of California San Diego
La Jolla, California, United States Recruiting -
Limber Prosthetics & Orthotics Inc
San Diego, California, United States Recruiting
Study contacts
- Principal investigator: Herb Barrack, CPO — LIMBER Prosthetics & Orthotics Inc
- Study coordinator: David Wing, MS
- Email: dwing@health.ucsd.edu
- Phone: 8585349315
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Optimize how you control a powered upper-limb prosthesis
This study tests new electrode configurations to improve myoelectric control for people with a below-elbow amputation using a prosthetic arm.
-
Methods to reproduce stumbles and slips during walking
This project tests three ways to create unexpected slips and stumbles during walking to compare responses in people who use a unilateral lower‑limb prosthesis and able‑bodied adults.
-
Tracking nerve-freezing during limb amputation to learn about post-operative and phantom limb pain
This registry will track how freezing nerves (cryoablation) is used during limb amputations to see if it affects post-operative and phantom limb pain in adults who have or will have an amputation.
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Assessment of patients with transfemoral amputation using osseointegrated implants
This study is testing if a new type of implant that attaches directly to the bone can help people with transfemoral amputation move better and feel more comfortable than traditional prosthetic sockets.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.