Clinical trial Recruiting at 1 site Interventional Ages 18 to 99

A new system to assess prosthetic socket fit for lower limb amputees

Official title: R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment

Run by North Carolina State University · NCT05425810 · Data updated 2026-11-12

This study is testing a new pressure sensing pad to see if it can help lower limb amputees get a better and more comfortable fit for their prosthetic sockets.

Quick facts

Study typeInterventional
Ages18 Years to 99 Years
SexAll
Enrollment3 (estimated)
SponsorNorth Carolina State University
Academic / other
Locations1 site (Raleigh, North Carolina)
StatusRecruiting
StartedApril 20, 2021
Main results expectedJanuary 30, 2026
Study endsFebruary 27, 2026
Registry record updatedMay 20, 2025
Trial IDNCT05425810 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are unilateral transtibial amputees with at least one year of experience using a prosthetic leg and no significant skin issues.

Probably not a fit

Patients with cognitive or visual impairments, neuropathy on the residual limb, or who are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and test an innovative pressure sensing pad designed to improve the fit of prosthetic sockets for lower limb amputees. The pad utilizes embedded nanotubes filled with gallium alloys to measure pressure distribution on the residual limb, providing visual feedback to prosthetists. Participants will undergo a series of visits where a test socket will be constructed and fitted, followed by comparisons of the new sensing pad against a commercially available reference sensor. The goal is to enhance the comfort and effectiveness of prosthetic fittings.

Why it matters

Potential benefit: If successful, this system could significantly improve the comfort and fit of prosthetic sockets, reducing the risk of pressure ulcers and enhancing the quality of life for amputees.

How similar studies have gone: While the approach of using a pressure sensing pad is innovative, similar studies have shown promise in improving prosthetic fit and comfort.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
* neuropathy observed on the residual limb
* regnant female

Where it's running

  • NC State University
    Raleigh, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.