RecruitingNot Applicable

An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

United States100 participantsStarted 2021-10-18

Plain-language summary

People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Socket Comfort Score

Timeframe: through study completion, an average of 1 year

Integral Absolute Error of Control System

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05124652

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Katheryn Allen, CPO

206-390-0228 kate@allyn.org

View on ClinicalTrials.gov More Lower Limb Amputation Below Knee (Injury) trials