Pressure InjuryPhase 3PROTECTNCT04328246
Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
A Phase 3 study testing IES System in people with Pressure Injury, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Injury
- What is being tested?
- IES System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2021to 14 Mar 2022
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows:
- Braden Scale score (Ranges from 6 to 23)
- 1 for Low Serum Albumin
- 1 for Type II Diabetes
- Anticipated length of stay of at least 4 days
- BMI < 35
- Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf.
Who cannot join
- Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
- Neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction
- Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction
- Rhabdomyolysis
- Use of a Pacemaker
- Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.
- Conditions
- Pressure Injury
- Being tested
- IES System, Standard of Care Therapy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IES SystemDevice
The IES system is composed of a stimulator and self-adhesive surface gel electrodes.
Standard of Care TherapyOther
Standard institutional practices for treating pressure injury.
| Study group | Role | What they receive |
|---|---|---|
| IES Device + Standard of Care | Experimental | Intermittent electrical stimulation system. Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10s every 10 minutes. The intervention is administered 24/7 and added to the standard of care management. Standard of care is defined as turning the patient every two hours. Receives: Device: IES System; Other: Standard of Care Therapy |
| Standard of Care | Active comparator | Standard of care treatment for pressure injuries is turning the patient every two hours. Receives: Other: Standard of Care Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical course of pressure injury over time
Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess for superiority of the experimental arm over the control arm.
Measured: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Secondary outcomes (8)
Clinical course of pressure injury in subgroups
Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess superiority.
Measured: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Kaplan-Meier Time-to-Event Analysis
A Kaplan Meier Curve and logrank Test (one-sided significance at p < 0.05) will be used to evaluate a difference in sacral and ischial pressure injury time-to-event morbidity between groups. An "event" is defined as the development of any stage/class of pressure ulcer.
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Cox Regression Analysis
Cox-regression analysis will be used to determine whether the implementation of the IES device is associated with a significant difference in sacral and ischial pressure injury time-to-event occurrence between treatment groups.
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Observed Counts of Pressure Injuries
Descriptive statistics and Chi-square testing will be used to compare in incidence rates and proportion between the treatment groups for sacral and ischial pressure injuries classified as Stage I-IV or Unstageable
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Onset Time
Descriptive statistics will be used to report the central tendency and spread of the onset time of a sacral and ischial pressure injury for both treatment groups and for injuries classified as Stage I-IV or Unstageable
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Relative Risk
Relative risk of sacral and ischial pressure injuries will be compared between treatment groups using a 2x2 contingency table with a 95% confidence interval.
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Duration of Inpatient Stay
Descriptive statistics will be used to report the central tendency and spread of the duration of inpatient stay for both treatment groups
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Description of adverse events related to IES
We will report frequency and severity of skin changes underlying the electrodes, categorized as i) transient erythema after electrode removal, ii) non-transient skin changes after electrode removal, iii) skin breakdown under electrode.
Measured: Final analysis will be performed at end of study (expected completion 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start26 Feb 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Why it stopped: Recruitment was not feasible at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabtronics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328246
- Sponsor's protocol ID
- IIT-0018
- Acronym
- PROTECT
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
- ClinicalTrials.gov ID
- NCT04328246
- Acronym / sponsor ID
- PROTECT / IIT-0018
- Conditions
- Pressure Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was not feasible at site.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Rehabtronics
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 31 Mar 2020 (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.
The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IES Device + Standard of Care | Experimental | Device: IES System, Other: Standard of Care TherapyIntermittent electrical stimulation system. Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10s every 10 minutes. The intervention is administered 24/7 and added to the standard of care management. Standard of care is defined as turning the patient every two hours. |
| Standard of Care | Active comparator | Other: Standard of Care TherapyStandard of care treatment for pressure injuries is turning the patient every two hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows:
- Braden Scale score (Ranges from 6 to 23)
- Anticipated length of stay of at least 4 days
- BMI < 35
- Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf.
Key exclusion criteria (6 listed)
- Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
- Neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction
- Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction
- Rhabdomyolysis
- Use of a Pacemaker
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 |
|---|---|---|
| IES SystemThe IES system is composed of a stimulator and self-adhesive surface gel electrodes. | Device | IES Device + Standard of Care |
| Standard of Care TherapyStandard institutional practices for treating pressure injury. | Other | IES Device + Standard of Care, Standard of Care |
Primary outcome
Clinical course of pressure injury over time
Time frame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess for superiority of the experimental arm over the control arm.
8 secondary outcomes
Clinical course of pressure injury in subgroups
Time frame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Kaplan-Meier Time-to-Event Analysis
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Cox Regression Analysis
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Observed Counts of Pressure Injuries
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Onset Time
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Relative Risk
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Duration of Inpatient Stay
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Description of adverse events related to IES
Time frame: Final analysis will be performed at end of study (expected completion 2 years)
Results and safety
The study was stopped early (reason given: Recruitment was not feasible at site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IES System in people with Pressure Injury, run by AHS Cancer Control Alberta at 1 site in Canada.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment was not feasible at site.). 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?
Clinical course of pressure injury over time (time frame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.