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New treatment option for Lower Limb Amputation Below Knee (Injury)
Official title R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
ClinicalTrials.gov ID: NCT05425810
What this study is testing
- What it's testing
- Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately.
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 99
You may be able to join if
- Unilateral transtibial amputees
- At least 1 year of experience using his/her prosthetic leg
- Has used the current socket for at least 6 months without a significant skin issue or major modification
- Can comfortably walk 3 mins without pausing to rest
- The fibula length on the residual limb must be greater than half of the length of the fibula on the unaffected side
You likely can't join if
- Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the...
- neuropathy observed on the residual limb
- regnant female
The study team makes the final eligibility decision.
Where it's taking place
- Raleigh, North Carolina, 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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raleigh, North Carolina, 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.