UnknownNot Applicable

NIH Release/Relock Socket

United States100 participantsStarted 2020-09-01

Plain-language summary

The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.

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.

Inclusion Criteria: * Had trans-tibial amputation at least 18 months prior to enrollment * Regularly wear a definitive prosthesis for at least 7 hours per week * Have a residual limb length of at least 9 cm * K2 or higher MFCL * Able to walk continuously with a prosthesis for at least 2 minutes at a time * Sit, stand, and negotiate a step of 5.0 cm Participants involved remotely will have to meet the following inclusion criteria: * Have a spare prosthesis * No cognitive issues * Good hand dexterity and strength (not frail) * Capable of communication over a video Zoom conference call. Exclusion Criteria: * Current presence of skin breakdown * Unable to satisfy inclusion criteria

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

Change in Limb Volume

Timeframe: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes

Prosthesis Evaluation Questionnaire (PEQ)

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

PROMIS-Fatigue

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

Socket Comfort Score (SCS)

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

Trial details

NCT IDNCT04305782

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Joan E Sanders, PhD

2062215872 jsanders@u.washington.edu

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

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.

What they're measuring

Change in Limb Volume

Timeframe: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes

Prosthesis Evaluation Questionnaire (PEQ)

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

PROMIS-Fatigue

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

Socket Comfort Score (SCS)

Timeframe: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.