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New study tests if adjustable sockets make prosthetics more comfortable

NCT ID NCT04038580

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared adjustable prosthetic sockets to conventional ones in 29 people with leg amputations. Participants tried different sockets and reported comfort, mobility, and quality of life. The goal was to see if adjustable sockets offer benefits over standard ones.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adjustable prosthetic sockets (Quatro, Infinite Socket, CJ Socket)
What this could lead to
If adjustable sockets prove more comfortable or functional, they could become a standard option for people with leg amputations, improving daily life.
What could go wrong
This is a small, completed study with only 29 participants, so results may not apply to everyone. Adjustable sockets may not work better for all users.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Aug 2019

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Unilateral lower-limb amputation * Six months of independent ambulation * Own and regularly wear a prosthesis with socket * Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator" Exclusion Criteria: * Pathology or injury of the intact limb * Medication that affects their ability to walk * Neurologic or cardiovascular disease * Significant vision problems * Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation Amputation; traumatic, leg, lower

Contacts and locations

Locations

  • Rosalind Franklin University

    Chicago, Illinois, 60064, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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