Stage 1 Pressure UlcerNCT05085288
The PROTECT 2 Study : Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
A study testing Intermittent electrical stimulation system (IES) treatment and turning patient every two hours and Turning population every two hours in people with Stage 1 Pressure Ulcer and Stage 2 Pressure Ulcer, run by The Cleveland Clinic at 3 sites in 2 countries.
Trial summary
Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 1 Pressure Ulcer, Stage 2 Pressure Ulcer
- What is being tested?
- Intermittent electrical stimulation system (IES) treatment and turning patient every two hours and Turning population every two hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Feb 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Wake Forest Unverisity
Winston-Salem, North Carolina, 27109
About this study
Official title: The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.
Read the detailed description
This is a two-arm, prospective randomized control trial assessing whether IES combined with the standard of care (treatment) is superior to the standard of care alone (control). The study is a parallel design, adaptive, non-blinded randomized controlled trial, and uses two-sided analysis. We plan interim analyses at each 25% of the N. Part of the early interim analyses (first and second) will involve reassessing the a priori assumptions on data distributions and variability use in sample size calculations and updating the study size needed. Treatment effect results will be shared with the Data Safety Monitoring Board (DSMB) to determine whether the study should be ended early for either futility or having demonstrated superiority of the intervention. Patients can be entered into the protocol multiple times with independent assessments of inclusion/exclusion criteria and new consent for each enrollment. At each enrollment they will be re-randomized to either experimental or control arm. For the purpose of overall survival analysis (the only endpoint with a delayed assessment of outcome), such patients will be excluded.
This trial studies adult inpatients in both ICU and non-ICU environments with either new or established stage 1 or stage 2 sacral and ischial pressure injuries. Patients with a pacemaker/AICD, rhabdomyolysis, gluteal skin breakdown, and unstable fractures at risk of displacement by IES are excluded. Patients with atrial or ventricular wires after cardiac surgery can be enrolled as long as they are not being paced or in the opinion of the treating physician are at high risk of requiring pacing.
Subjects will be assessed for pressure injury status from point of randomization to discharge, death, or a minimum of 30 days. Device utilization and data collection can stop after 14 days in a non-ICU environment or when a total of 30 days of data collection has been met. If subjects are in the ICU longer than 30 days or when the combined total of ICU and less than 14 non-ICU days is greater than 30 days, the assessment and use of the device may continue after 30 days. Following entry into the study, participants will receive either the IES device in addition to the standard of care (treatment group) or the standard of care alone (control group). The study is expected to complete accrual within 12-18 months. Participant treatment will occur for the same amount of time as pressure injury assessment occurs as described above.
- Conditions
- Stage 1 Pressure Ulcer, Stage 2 Pressure Ulcer
- Being tested
- Intermittent electrical stimulation system (IES) treatment and turning patient every two hours, Turning population every two hours
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent electrical stimulation system (IES) treatment and turning patient every two hoursDevice
The investigators propose to assess whether addition of the IES system and the use of standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 and stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population.
Turning population every two hoursOther
The investigators propose to assess whether current standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent electrical stimulation system (IES) treatment Group | Active comparator | Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes. Receives: Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours |
| Standard of care Group | Active comparator | Standard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care. Receives: Other: Turning population every two hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of adding the IES System to standard of care
Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care on the primary outcome of sacral and ischial pressure injury score measured over time.
Measured: 24 hours of admission to the ICU or non-ICU hospital service
Compare using the IES oppose to only standard care
Investigators will assess time to resolution of the ulcer
Measured: 24 hours of admission to the ICU or non-ICU hospital service
Secondary outcomes (2)
Compare IES to standard care
Time to resolution of ulcer
Measured: 24 hours of admission to the ICU or non-ICU hospital service
Evaluate treatment effect heterogeneity across levels of the following patient factors
A variety of patient factors will be evaluated for treatment effect heterogeneity
Measured: 24 hours of admission to the ICU or non-ICU hospital service until discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study is on administrative enrollment hold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 1 Pressure UlcerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chase Donaldson, MD, Principal investigator, The Cleveland ClinicAndrea Kurz, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085288
- Sponsor's protocol ID
- 21-1009
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Donaldson C, de Abreu MG, Mascha EJ, Rowbottom J, Harvester E, Khanna A, Sura T, Sessler DI, Patarroyo FR, Gulluoglu A, Zajic P, Chauhan U, Essber H, Kurz A. Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial. Trials. 2024 May 10;25(1):313. doi: 10.1186/s13063-024-08085-x.
PubMed 38730383
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05085288
- Acronym / sponsor ID
- 21-1009
- Conditions
- Stage 1 Pressure Ulcer, Stage 2 Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is on administrative enrollment hold.
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.
Detailed description
This is a two-arm, prospective randomized control trial assessing whether IES combined with the standard of care (treatment) is superior to the standard of care alone (control). The study is a parallel design, adaptive, non-blinded randomized controlled trial, and uses two-sided analysis. We plan interim analyses at each 25% of the N. Part of the early interim analyses (first and second) will involve reassessing the a priori assumptions on data distributions and variability use in sample size calculations and updating the study size needed. Treatment effect results will be shared with the Data Safety Monitoring Board (DSMB) to determine whether the study should be ended early for either futility or having demonstrated superiority of the intervention. Patients can be entered into the protocol multiple times with independent assessments of inclusion/exclusion criteria and new consent for each enrollment. At each enrollment they will be re-randomized to either experimental or control arm. For the purpose of overall survival analysis (the only endpoint with a delayed assessment of outcome), such patients will be excluded.
This trial studies adult inpatients in both ICU and non-ICU environments with either new or established stage 1 or stage 2 sacral and ischial pressure injuries. Patients with a pacemaker/AICD, rhabdomyolysis, gluteal skin breakdown, and unstable fractures at risk of displacement by IES are excluded. Patients with atrial or ventricular wires after cardiac surgery can be enrolled as long as they are not being paced or in the opinion of the treating physician are at high risk of requiring pacing.
Subjects will be assessed for pressure injury status from point of randomization to discharge, death, or a minimum of 30 days. Device utilization and data collection can stop after 14 days in a non-ICU environment or when a total of 30 days of data collection has been met. If subjects are in the ICU longer than 30 days or when the combined total of ICU and less than 14 non-ICU days is greater than 30 days, the assessment and use of the device may continue after 30 days. Following entry into the study, participants will receive either the IES device in addition to the standard of care (treatment group) or the standard of care alone (control group). The study is expected to complete accrual within 12-18 months. Participant treatment will occur for the same amount of time as pressure injury assessment occurs as described above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent electrical stimulation system (IES) treatment Group | Active comparator | Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hoursCharged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes. |
| Standard of care Group | Active comparator | Other: Turning population every two hoursStandard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent electrical stimulation system (IES) treatment and turning patient every two hoursThe investigators propose to assess whether addition of the IES system and the use of standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 and stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population. | Device | Intermittent electrical stimulation system (IES) treatment Group |
| Turning population every two hoursThe investigators propose to assess whether current standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries. | Other | Standard of care Group |
Primary outcome
Efficacy of adding the IES System to standard of care
Time frame: 24 hours of admission to the ICU or non-ICU hospital service
Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care on the primary outcome of sacral and ischial pressure injury score measured over time.
Compare using the IES oppose to only standard care
Time frame: 24 hours of admission to the ICU or non-ICU hospital service
Investigators will assess time to resolution of the ulcer
2 secondary outcomes
Compare IES to standard care
Time frame: 24 hours of admission to the ICU or non-ICU hospital service
Evaluate treatment effect heterogeneity across levels of the following patient factors
Time frame: 24 hours of admission to the ICU or non-ICU hospital service until discharged
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 38730383Donaldson C, de Abreu MG, Mascha EJ, Rowbottom J, Harvester E, Khanna A, Sura T, Sessler DI, Patarroyo FR, Gulluoglu A, Zajic P, Chauhan U, Essber H, Kurz A. Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial. Trials. 2024 May 10;25(1):313. doi: 10.1186/s13063-024-08085-x.
Related trials for Stage 1 Pressure Ulcer
Recruiting
Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers
Pressure Ulcer Stage 1, Pressure Ulcers Stage II
RecruitingPhase 2
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
Pressure Ulcer, Stage IV, Osteomyelitis
Recruiting
Study on the Use of Lateral Decubitus Position in Left Breast Cancer Patients Undergoing Adjuvant Radiotherapy
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chase Donaldson, MD principal investigator
The Cleveland Clinic
Andrea Kurz, MD study chair
The Cleveland Clinic
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent electrical stimulation system (IES) treatment and turning patient every two hours and Turning population every two hours in people with Stage 1 Pressure Ulcer and Stage 2 Pressure Ulcer, run by The Cleveland Clinic at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of adding the IES System to standard of care (time frame: 24 hours of admission to the ICU or non-ICU hospital service). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05085288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.