3D printed customized prosthetic legs for amputees
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | LIMBER Prosthetics & Orthotics Inc Industry-sponsored |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06648798 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are diabetic or have significant health issues that could affect their participation may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
La Jolla, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.