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Behavioural Intervention
IES Device + Standard of Care for Pressure Ulcer (PROTECT Trial)
Phase 3
Waitlist Available
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Braden Scale score (Ranges from 6 to 23)
1 for Low Serum Albumin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final analysis will be performed at end of study (expected completion 2 years)
Awards & highlights
PROTECT Trial Summary
This trial will compare the effectiveness of a new pressure injury treatment to the current standard of care.
Eligible Conditions
- Pressure Ulcer
PROTECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROTECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ final analysis will be performed at end of study (expected completion 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final analysis will be performed at end of study (expected completion 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical course of pressure injury over time
Secondary outcome measures
Clinical course of pressure injury in subgroups
Cox Regression Analysis
Description of adverse events related to IES
+5 morePROTECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IES Device + Standard of CareExperimental Treatment2 Interventions
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.
Group II: Standard of CareActive Control1 Intervention
Standard of care treatment for pressure injuries is turning the patient every two hours.
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,208 Total Patients Enrolled
RehabtronicsUNKNOWN
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