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Prosthetists may uncover silent health issues in amputees

NCT ID NCT05410548

Knowledge-focused Sponsor: University of Delaware 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether prosthetists—specialists who fit artificial limbs—can screen for common but often unnoticed health problems like depression, nerve damage, and poor blood flow in people who have had a leg amputation. Seventy participants were split into two groups: one received standard care, and the other also got screenings and education from a prosthetist. The goal was to see if this extra step improves patient awareness and satisfaction without overloading the healthcare system.

What this could mean

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

Active substance
comorbidity screening by prosthetists
What this could lead to
If successful, this approach could help prosthetists become part of a team that catches hidden health problems early, improving overall care for people after amputation.
What could go wrong
This was a small, early-stage study with only 70 participants, so results may not apply to everyone. It tested screening, not treatment, so direct health benefits are uncertain.

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

70 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 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 to 85 years

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: * English-speaking and -reading * Unilateral transtibial (i.e., below-knee) or transfemoral (i.e., above-knee) amputation * Utilization of a prosthesis for at least 1 year * Willingness to have screening results communicated to their primary care provider * Receiving prosthetic care at Independence Prosthetics-Orthotics, Inc. Exclusion Criteria: * Cognitive impairment precluding ability to consent to study participation * Contralateral limb amputation greater than toe-level * Severe vision or hearing loss * Receipt of a replacement prosthetic component within the 3 months prior to study enrollment * Hospitalization within the 3 months prior to study enrollment

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Conditions

The condition(s) this trial relates to.

Back Pain Depression depressive disorder limb ischemia Low Back Pain neuritis peripheral arterial disease peripheral nervous system disorder Psychological Well-Being

As listed by the trial registrant

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

Amputation Depression Limb ischemia Low back pain Neuropathy;peripheral

Contacts and locations

Locations

  • University of Delaware STAR Campus

    Newark, Delaware, 19713, United States

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