Intermittent Electrical Stimulation for Pressure Sores

Recruiting at 2 trial locations

Overseen By Fabio Rodriguez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Unstable fractures, Rhabdomyolysis, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Intermittent Electrical Stimulation (IES) can heal pressure sores, painful wounds caused by prolonged immobility. The trial compares two groups: one receiving IES treatment with small electrical pulses and another receiving standard wound care. It targets individuals with stage 1 or 2 pressure sores on their lower back or buttocks who can consent to participate. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for pressure sores.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Intermittent Electrical Stimulation is safe for treating pressure sores?

Research shows that electrical stimulation often treats wounds like pressure sores. Studies have found this method generally safe, helping wounds heal faster and reducing pain. One study discovered that tiny electrical currents improved healing compared to standard treatment alone. Another study suggested that electrical stimulation might increase the number of pressure sores that heal and speed up the healing process.

Although specific information on the treatment used in this trial is limited, similar electrical stimulation methods have a good safety record. These treatments are non-invasive, avoiding surgery or injections, which usually means fewer risks. Overall, research suggests that patients tolerate electrical stimulation well, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intermittent Electrical Stimulation (IES) for pressure sores because it offers a new, non-invasive way to prevent and manage these wounds. Unlike standard care, which relies on wound dressings, repositioning, and other traditional methods, IES uses charged pulses to stimulate the gluteus maximus muscles. This stimulation occurs at a frequency of 30 Hz for 10 seconds every 10 minutes, potentially improving blood flow and reducing the risk of sores developing without interrupting daily activities. By targeting muscle activity directly, IES could enhance healing and offer a novel approach to pressure sore management.

What evidence suggests that Intermittent Electrical Stimulation is effective for pressure sores?

Research has shown that Intermittent Electrical Stimulation (IES), which participants in this trial may receive, can help heal pressure sores—wounds that develop from prolonged immobility. Studies have found that gentle electrical currents can accelerate healing by promoting faster tissue regeneration. This method has benefited people with spinal cord injuries in treating and preventing these sores. Overall, evidence suggests that IES effectively supports the healing of pressure injuries. ^{1 5 6 7 8}

Who Is on the Research Team?

Chase Donaldson, MD

Principal Investigator

The Cleveland Clinic

Andrea Kurz, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the IES device in addition to the standard of care or the standard of care alone. Treatment continues from randomization to discharge, death, or a minimum of 30 days.

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection continuing for up to 30 days in non-ICU environments or longer if in ICU.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Electrical Stimulation (IES)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intermittent electrical stimulation system (IES) treatment Group Active Control 1 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 Group Active Control 1 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.

Intermittent Electrical Stimulation (IES) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Approved in European Union as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Approved in Canada as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Functional electrical stimulation (FES) applied to the quadriceps in seated spinal cord injured (SCI) subjects significantly reduced ischial pressures, with average drops of 44 mmHg on the right and 27 mmHg on the left buttock.

The effectiveness of FES in reducing pressure sores was more pronounced in subjects with larger knee moments, suggesting that FES could be a valuable preventive tool for managing pressure sores in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of seating pressure using FES in patients with spinal cord injury. A preliminary report. Ferguson, AC., Keating, JF., Delargy, MA., et al.[2006]

In a study involving 203 patients with knee osteoarthritis, all treatment groups (TENS, IFCs, SWD) showed significant improvements in pain and function, but there were no major differences in effectiveness among the active treatments compared to sham interventions.

Patients receiving active treatments had a significantly lower intake of paracetamol compared to those in sham groups, indicating that physical therapy modalities may enhance pain relief beyond exercise and education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Atamaz, FC., Durmaz, B., Baydar, M., et al.[2013]

An educational program significantly improved healthcare providers' knowledge about using electrical stimulation (E-Stim) for treating pressure injuries, with knowledge scores increasing from 55.9% to 78.4% after the online modules and remaining at 78.0% after the hands-on workshop.

While knowledge increased, hands-on workshops were essential for positively changing attitudes towards E-Stim use, indicating that practical experience is crucial for effective implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quasi-Experimental Evaluation of an Education Program for the Use of Electrical Stimulation Therapy to Heal Pressure Injuries. Orr, L., Houghton, P., Holyoke, P., et al.[2021]

In a study involving 280 individuals with chronic low back pain, both transcutaneous nerve stimulation (TENS) and interferential current (IFC) showed immediate pain relief, with IFC at 4 kHz and 100 Hz being particularly effective.

All treatment groups significantly reduced pain intensity compared to placebo, indicating that both TENS and IFC can be effective non-invasive options for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial. Dias, LV., Cordeiro, MA., Schmidt de Sales, R., et al.[2021]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced exercise-induced pain (EIP) by 12% during isometric contractions and improved time to exhaustion by 38% in a study involving 40 healthy participants.

TENS also enhanced performance in a 16.1 km cycling time trial, resulting in a ~2% faster completion time, indicating that reducing pain can lead to better endurance performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation reduces exercise-induced perceived pain and improves endurance exercise performance. Astokorki, AHY., Mauger, AR.[2021]

Intermittent electrical stimulation (IES) was found to be safe and feasible for preventing pressure ulcers in a study involving 20 immobile patients aged 19 to 86, with no pressure ulcers developing during the study period.

Nurses reported that IES was easy to use and could be integrated into routine care, taking only a few minutes to apply and remove, indicating its practicality in an intensive care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Intermittent Electrical Stimulation to Prevent Deep Tissue Injury in the Intensive Care Unit. Kane, A., Warwaruk-Rogers, R., Ho, C., et al.[2019]

Electrical muscle stimulation (EMS) effectively reduces pressure under the ischial tuberosity, which is crucial for preventing pressure sores, as shown in tests with three able-bodied subjects.

The study indicates that EMS can redistribute pressure on seating surfaces without causing fatigue in able-bodied individuals, suggesting its potential for safe, long-term use in pressure sore prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation for pressure variation at the seating interface. Levine, SP., Kett, RL., Cederna, PS., et al.[2006]

Intermittent electrical stimulation (IES) was tested in a study involving rats to prevent deep tissue injury (DTI) caused by pressure ulcers, showing that all IES treatment paradigms significantly reduced muscle damage compared to conventional pressure relief methods.

Conventional pressure relief, similar to a wheelchair push-up every 10 minutes, was found to be inadequate for preventing DTI, highlighting the potential of IES as a more effective intervention for preventing deep pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of intermittent electrical stimulation on the prevention of deep tissue injury: varying loads and stimulation paradigms. Curtis, CA., Chong, SL., Kornelsen, I., et al.[2011]

In a study involving 30 healthy volunteers, interferential currents (IFC) were found to significantly reduce pain intensity compared to sham electrotherapy, indicating its potential effectiveness for pain management.

However, there was no significant difference in pain relief between IFC and transcutaneous electrical nerve stimulation (TENS), suggesting that both methods may offer similar analgesic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the analgesic effects of interferential currents and transcutaneous electrical nerve stimulation on experimentally induced ischemic pain in otherwise pain-free volunteers. Johnson, MI., Tabasam, G.[2022]

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984413/

Electrical stimulation for treating pressure ulcers - PMC Pulsed low‐intensity direct current (PLIDC) is effective in healing chronic decubitus ulcers in stages II and III. Journal of Investigative Dermatology 1992 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4231958/

A systematic review of electrical stimulation for pressure ulcer ... Electrical stimulation (ES) can confer benefit to pressure ulcer (PU) prevention and treatment in spinal cord injuries (SCIs). However, clinical guidelines ...

3. alliedhealth.ceconnection.com alliedhealth.ceconnection.com/ovidfiles/00129334-202306000-00004.pdf

Electrical Stimulation in the Treatment of Pressure Injuries In recent years, an increasing number of studies have in- vestigated the influence of physical modalities such as electrical stimulation (ES) on wound healing.

4. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2024/ra/d4ra04258a

a novel therapeutic strategy to heal biological wounds This non-invasive technique utilizes low-level electrical currents to promote tissue regeneration and expedite the wound healing process.

5. tandfonline.com tandfonline.com/doi/full/10.2147/CWCMR.S101323

Electrical stimulation therapy to promote healing of chronic ... Electrical stimulation therapy (EST) is an adjunctive therapy designed to deliver low levels of electrical current to tissues in and around ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965206X21001327

Electrical microcurrent stimulation therapy for wound healing Microcurrents are more effective than standard wound care alone. Microcurrents are effective and safe in improving wound area, healing time, and pain.

7. beonbrand.getbynder.com beonbrand.getbynder.com/m/642329891c1f4c19/original/Electrical-Stimulation-for-the-Treatment-of-Wounds.pdf

Electrical Stimulation for the Treatment of Wounds Electrostimulation had greatest efficacy when the active electrode was over the wound and high-voltage pulsed current was used (SMD=0.8; 95% CI, ...

8. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Electro-Electromagnetic-Therapy-Treating-Wounds.pdf

2.01.57 Electrostimulation and Electromagnetic Therapy for ... Overall, the authors concluded that electrical stimulation probably increased the proportion of pressure ulcers healed and the rate of healing ( ...