LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
LIMBER Prosthetics & Orthotics Inc · with University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06648798
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 30
- US sites recruiting
- 2
- Study start
- December 20, 2023
- Record last updated
- November 26, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Limber Limb
Conditions: Amputation of Lower Limb; Prosthesis; Non-inferiority Trial of Prothesis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons, aged 18 to 75
- In good general health as determined by clinical site monitor
- Weight \< 125kg
- Are not diabetic (self reported)
- Be a unilateral transtibial amputee of more than 1 year since amputation
- Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
- Live in the Southern California region (within 50 miles of UCSD)
- Has sufficient sensation in residual limb as tested by the clinical site monitor
- 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
- Not currently using a prosthetic device
- Prosthetic device with active motors, sensors, etc.
- Pregnancy (due to fall risk)
- Diabetic (due to poor limb sensation), self reported
- No under 18 (due to inability to consent)
- No over 75 (due to fall risk)
- Poor proprioception or sensation at the residual limb
Recruiting US locations
University of California San Diego
La Jolla, CA 92093
Site contact: David R Wing, MS · 858-534-9315 · dwing@health.ucsd.edu
Limber Prosthetics & Orthotics Inc
San Diego, CA 92111
Site contact: Luca De Vivo, PhD · 310-602-9091 · luca@limberprosthetics.com
Study contacts (from the official record)
- David Wing, MS · 8585349315 · dwing@health.ucsd.edu
- Michael Higgins, MS · 8585349315 · mdhiggins@health.ucsd.edu