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Could a gentle electric zap heal bedsores faster?

NCT ID NCT05085288

Disease control Sponsor: The Cleveland Clinic 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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a device that delivers mild electrical pulses (intermittent electrical stimulation) to standard care (turning patients every two hours) helps heal stage 1 or 2 bedsores on the lower back or tailbone. About 1,100 hospitalized adults will be randomly assigned to receive either standard care alone or standard care plus the electrical stimulation device. The goal is to see if the device speeds healing and prevents sores from getting worse.

What this could mean

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

Active substance
intermittent electrical stimulation system (IES)
What this could lead to
If it works, this could provide a new, non-drug way to help heal bedsores and prevent them from getting worse in critically ill patients.
What could go wrong
The trial is currently suspended, so results are delayed. It is also an early-stage study, and the benefit over standard turning alone is not yet proven.

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

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Either new or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU or non-ICU environments. * Participants capable of giving informed consent, or if propitiate, participants having an acceptable individual capable of giving consent on the participant's behalf. Exclusion Criteria: * Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction. * Rhabdomyolysis * Presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker. * Skin breakdown or malignant skin involvement over the gluteal regions that would preclude the use of surface electrodes * BMI \> 40

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Conditions

The condition(s) this trial relates to.

decubitus ulcer

As listed by the trial registrant

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

Stage 1 pressure ulcer Stage 2 pressure ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Univeristy of Graz

    Graz, A-8010, Austria

  • Wake Forest Unverisity

    Winston-Salem, North Carolina, 27109, United States