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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | October 18, 2021 |
| Main results expected | March 2027 |
| Study ends | June 2027 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT05124652 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.
-
Try the Caesar take-home foot for everyday use and running
This trial tests whether people with below‑knee amputations who are interested in running can use the bimodal Caesar foot at home for two months to see if it improves mobility and daily activity.
-
Improving balance and control for below-knee amputees using advanced prosthetics
This study tests if using advanced powered prosthetic ankles controlled by muscle signals can help people with below-knee amputations improve their balance and movement compared to regular prosthetics.
-
Improving walking skills for lower limb prosthesis users on uneven terrain
This study tests a walking program for people using lower limb prostheses to see if training on uneven surfaces helps them walk better and feel more confident.
-
Evaluating brain and technology interaction after below-knee amputation
This study is testing how a new passive prosthetic ankle helps people who have had a leg amputated improve their walking and brain function compared to those without amputations.
-
A new system to assess prosthetic socket fit for lower limb amputees
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.