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Electrical Stimulation
Intermittent Electrical Stimulation for Pressure Sores
N/A
Recruiting
Led By Chase Donaldson, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU or non-ICU environments
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours of admission to the icu or non-icu hospital service
Awards & highlights
Study Summary
This trial will test whether electrical stimulation can help heal pressure injuries.
Who is the study for?
This trial is for patients with new or existing stage 1 or 2 pressure ulcers near the tailbone or hip area, in both ICU and non-ICU settings. Participants must be able to consent, or have someone who can consent for them. It's not for those with certain fractures, muscle breakdown (rhabdomyolysis), heart device implants like pacemakers, skin issues that prevent electrode use on the buttocks, or a BMI over 40.Check my eligibility
What is being tested?
The PROTECT 2 Study tests if using an Intermittent Electrical Stimulation (IES) system along with regular turning every two hours helps heal pressure injuries better than just turning patients every two hours. This study randomly assigns participants to either treatment group across multiple centers.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation and possible skin irritation where electrodes are placed. Since this involves standard care procedures as well, risks associated with patient handling and repositioning also apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new or existing mild to moderate pressure sore on my lower back or buttocks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours of admission to the icu or non-icu hospital service
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours of admission to the icu or non-icu hospital service
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare using the IES oppose to only standard care
Efficacy of adding the IES System to standard of care
Secondary outcome measures
Compare IES to standard care
Evaluate treatment effect heterogeneity across levels of the following patient factors
Trial Design
2Treatment groups
Active Control
Group I: Intermittent electrical stimulation system (IES) treatment GroupActive Control1 Intervention
Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.
Group II: Standard of care GroupActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,029 Previous Clinical Trials
1,363,978 Total Patients Enrolled
Chase Donaldson, MDPrincipal InvestigatorThe Cleveland Clinic
Andrea Kurz, MDStudy ChairThe Cleveland Clinic
4 Previous Clinical Trials
6,851 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unstable fractures in my spine, pelvis, or hip.I have a permanent pacemaker or AICD, or I might need an external pacemaker.I have had rhabdomyolysis.You have a very high body mass index (BMI).I do not have skin issues or cancer on my buttocks that would prevent the use of surface electrodes.I have a new or existing mild to moderate pressure sore on my lower back or buttocks.I can give my own consent or have someone who can consent for me.
Research Study Groups:
This trial has the following groups:- Group 1: Intermittent electrical stimulation system (IES) treatment Group
- Group 2: Standard of care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial currently have capacity for additional enrollees?
"Clinicaltrials.gov reports that recruitment for this medical study is ongoing, having begun on February 8th of 2022 and last been updated on April 29th of the same year."
Answered by AI
What is the approximate number of participants in this research project?
"Affirmative. Clinicaltrials.gov data corroborates that this clinical trial, posted on February 8th 2022, is actively enrolling participants. Approximately 1,100 individuals must be enrolled from 2 different medical facilities."
Answered by AI
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