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New treatment option for Amputation of Lower Limb
Official title LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
ClinicalTrials.gov ID: NCT06648798
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely 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)
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.