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Bionic ankles under the microscope: can they ease pressure on amputees?

NCT ID NCT05112679

Knowledge-focused Sponsor: Indiana University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how powered ankle prostheses change the pressure inside the prosthetic socket and the health of the residual limb in people with below-knee amputations. Six adults who already use a standard prosthetic leg walked on level ground with different types of prostheses to compare socket pressures and skin blood flow. The goal is to help design better-fitting, more comfortable artificial limbs.

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

6 people

The number who actually took part.

Started

Nov 2021

Finished

Jul 2023

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: * Ages 18 and above * Weight ≤ 280 lb * Ambulate at a K3 level or higher-level determined from patient EHR * At least 3 months post-amputation per physician discretion * Residual limb length greater than 4.5 inches * Use of a passive prosthesis * Unilateral transtibial amputees * Must be able to ambulate without any assistive devices * Subjects must be able to follow directions and give informed consent on their own Exclusion Criteria: * Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb * Other amputees * Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol * Women who are pregnant or who plan to become pregnant in the near future * Individuals diagnosed with renal failure * Participants unwilling to wear a cloth face covering for the duration of each visit

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Conditions

The condition(s) this trial relates to.

decubitus ulcer injury Mobility Limitation Prosthesis Failure

As listed by the trial registrant

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

Amputation Amputation; traumatic, foot Limb deficiencies Mobility limitation Pressure ulcer, ankle Prosthesis durability Prosthesis user Skin wound

Contacts and locations

Locations

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46228, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.