What this study is
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).
What's being tested
- Limber Limb
Intervention · DEVICE
Participants will be 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).
Study details
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
- Conditions
- Amputation of Lower Limb · Prosthesis · Non-inferiority Trial of Prothesis
- Enrolling
- 30 people
- Starts
- 2023-12-20
- Est. completion
- 2026-10-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of California San Diego
La Jolla, California, United States
- David R Wing, MS · Contact858-534-9315dwing@health.ucsd.edu
- Michael Higgins, MS · Contact8585349315mdhiggins@health.ucsd.edu
- Falko Kuester, Ph.D · Principal investigator
RecruitingLimber Prosthetics & Orthotics Inc
San Diego, California, United States
- Luca De Vivo, PhD · Contact310-602-9091luca@limberprosthetics.com
- Herb Barrack, CPO · Contact(310) 602-9091herb@limberprosthetics.com
- Herb Barrack, CPO · Principal investigator
- Luca De Vivo, PhD · Sub-investigator
Recruiting
Study team
Sponsor
LIMBER Prosthetics & Orthotics Inc
Study ID 803632
Principal investigator
Herb Barrack, CPO
LIMBER Prosthetics & Orthotics Inc
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.