Using electrical stimulation to treat pressure injuries
The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
This study is testing if using electrical stimulation along with regular care can help people with early-stage pressure injuries heal better than just using regular care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Winston-Salem, North Carolina and 2 other locations) |
| Trial ID | NCT05085288 on ClinicalTrials.gov |
What this trial studies
This multicentered randomized controlled trial evaluates the effectiveness of Intermittent Electrical Stimulation (IES) in reducing the progression and promoting the healing of stage 1 and stage 2 pressure injuries in patients. The study compares IES combined with standard care against standard care alone in both ICU and non-ICU settings. It employs a parallel design with adaptive features, allowing for interim analyses to reassess sample size and treatment effects. Patients can be enrolled multiple times, with independent assessments for each enrollment, ensuring robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates include adult inpatients with new or established stage 1 or stage 2 sacral or ischial pressure injuries.
Not a fit: Patients with unstable fractures, certain cardiac devices, or severe skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing outcomes for patients with pressure injuries.
How similar studies have performed: Other studies have shown promise with similar electrical stimulation approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina and 2 other locations
- Wake Forest Unverisity — Winston-Salem, North Carolina, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Univeristy of Graz — Graz, Austria (Recruiting)
Study contacts
- Principal investigator: Chase Donaldson, MD — The Cleveland Clinic
- Study coordinator: Fabio Rodriguez
- Email: RODRIGF3@ccf.org
- Phone: 216-444-9950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.