Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Automatically adjusting prosthetic socket for below-knee amputees

Official title: An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

Run by University of Washington · NCT05124652 · Data updated 2026-11-12

This study is testing a new type of prosthetic socket that automatically adjusts to fit better for people with below-knee amputations, making it more comfortable and reducing the risk of pain or skin problems.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedOctober 18, 2021
Main results expectedMarch 2027
Study endsJune 2027
Registry record updatedMay 7, 2026
Trial IDNCT05124652 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who have had a transtibial amputation for at least 12 months and regularly experience limb volume fluctuations.

Probably not a fit

Patients with neuropathy, reduced skin sensation, or those who regularly use an assisted device 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 research focuses on developing an innovative prosthetic socket system that automatically adjusts to accommodate daily fluctuations in the volume of a residual limb for individuals with transtibial amputations. The goal is to enhance the fit of the prosthesis, thereby reducing discomfort and preventing complications such as pain and skin breakdown. Participants will include both prosthesis users who experience volume changes and certified prosthetists who treat these patients. The study aims to create a more user-friendly solution that eliminates the need for manual adjustments throughout the day.

Why it matters

Potential benefit: If successful, this study could significantly improve the comfort and quality of life for individuals with below-knee amputations by providing a better-fitting prosthesis.

How similar studies have gone: While there have been studies on prosthetic adjustments, this approach of automatic adjustment is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 18 years or older
* Unilateral or bilateral trans-tibial amputation at least 12 months prior
* Have a limb of length 9 cm or greater
* Are capable of at least 5 minutes of continuous walking
* Are capable of at least 1 hour of intermittent walking
* Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads
* Have adequate sensation to verbalize a socket that is too large or too small to be tolerated
* Do not regularly use assistive devices (e.g., cane, walker) for ambulation
* Do not have open wounds on their residual limb at the time of enrollment

Where it's running

  • William H. Foege Hall
    Seattle, Washington, United States
    Recruiting

Study contacts

  • Principal investigator: Joan E Sanders, PhD — University of Washington
  • Study coordinator: Katheryn Allen, CPO
  • Email: kate@allyn.org
  • Phone: 206-390-0228

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.