PWI + ES for Spinal Cord Injury Wound Care

((SCI) Trial)

Overseen By Erin Weeks, PT, DPT,WS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to heal wounds in people with spinal cord injuries. Researchers are examining three treatments: pulsed wound irrigation (a special cleaning technique), electrical stimulation (a therapy using mild electrical currents), and a combination of both. The goal is to determine which method best heals wounds. Individuals with a spinal cord injury and a pressure sore on the lower back or hips might qualify for this trial. Participants must receive care at Carolinas Rehabilitation Charlotte and agree to treatment by a physical therapist. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could significantly improve wound healing for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pulsed wound irrigation (PWI) is likely safe for treating wounds. In studies involving individuals with large burns, PWI improved skin graft success and reduced wound bacteria, indicating it is generally well-tolerated.

For electrical stimulation (ES), studies indicate it is safe and effective for accelerating the healing of pressure sores by attracting essential healing cells. Other research found that ES is safe when applied to the back in individuals with spinal cord injuries (SCI).

When combined, PWI and ES are considered safe for aiding wound healing in people with SCI. Studies support both methods, demonstrating their effectiveness in wound care and their good tolerance by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injury wound care because they offer innovative approaches to promoting healing. Unlike standard wound care methods like regular cleaning and bandaging, pulsed wound irrigation (PWI) uses a pressurized saline solution to mechanically loosen necrotic tissue, potentially speeding up the healing process. Electrical stimulation (ES) distinguishes itself by enhancing the body's natural healing mechanisms through galvanotaxis, which attracts essential immune cells to the wound site. The combination of ES and PWI could provide a synergistic effect, integrating mechanical and electrical strategies to accelerate wound closure in ways that traditional methods do not.

What evidence suggests that this trial's treatments could be effective for spinal cord injury wound care?

Research has shown that pulsed wound irrigation (PWI), one of the treatments in this trial, can aid in healing wounds in people with spinal cord injuries (SCI). Studies found that PWI improved healing rates for serious pressure sores compared to standard treatments. Another treatment option in this trial is electrical stimulation (ES), which research indicates can speed up wound healing by attracting important immune cells. The trial will also study the combination of PWI and ES, which might enhance these effects, as both methods have shown promise in improving wound healing for those with SCI. These treatments aim to accelerate and improve wound healing by using irrigation to clean and ES to boost the body's natural healing processes. ^{1 3 6 7 8}

Who Is on the Research Team?

Erin Weeks, PT,DPT, CWS

Principal Investigator

Carolinas Rehabilitation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with spinal cord injuries and pressure sores on the lower back or hip, who are inpatient at Carolinas Rehabilitation Charlotte. They must be able to consent to treatment and have a wound severity score above 31. People can't join if they're pregnant, can't tolerate pain from treatments, cannot consent, or have less severe wounds.

Inclusion Criteria

I am over 18 years old.

Bates-Jensen Wound Assessment Tool (BWAT) >31 on initial evaluation

My doctor has ordered physical therapy for my wound care.

Exclusion Criteria

Bates-Jensen Wound Assessment Tool (BWAT) <30 on initial evaluation

I am unable to understand or sign the consent form by myself.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive wound care treatments including pulsed wound irrigation (PWI) and/or electrical stimulation (ES) to promote wound healing

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• electrical stimulation (ES)
• electrical stimulation (ES) and pulsed wound irrigation (PWI)
• pulsed wound irrigation (PWI)

Trial Overview The study tests how well different physical therapy techniques help heal wounds in spinal cord injury patients. It compares pulsed wound irrigation (PWI), electrical stimulation (ES), and their combination to see which is most effective.

How Is the Trial Designed?

Group I: pulsed wound irrigation (PWI) Experimental Treatment 1 Intervention

The necrotic wound is irrigated with normal saline (0.9%) with an 8-12 pounds per square inch pressure (PSI) to provide a mechanical force to loosen necrotic tissue for wound healing

Group II: electrical stimulation (ES) and pulsed wound irrigation (PWI) Experimental Treatment 1 Intervention

The necrotic wound is irrigated with normal saline (0.9%) with an 8-12 pounds per square inch pressure (PSI) to provide a mechanical force to loosen necrotic tissue for wound healing and ES to promote the migration of cells based on natural cell polarity known as galvanotaxis, enhancing and mimicking the natural current of injury. By recreating the natural electrical fields of the skin, ES attracts immune cells vital to healing to wound to facilitate wound closure

Group III: electrical stimulation (ES) Experimental Treatment 1 Intervention

ES works to promote the migration of cells based on natural cell polarity known as galvanotaxis, enhancing and mimicking the natural current of injury. By recreating the natural electrical fields of the skin, ES attracts immune cells vital to healing to wound to facilitate wound closure

electrical stimulation (ES) is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Electrical Stimulation Therapy for:

• Pressure ulcers in patients with spinal cord injury

Approved in European Union as Electrical Stimulation Therapy for:

• Hard-to-heal wounds including pressure injuries and diabetic foot ulcers

Approved in United States as Electrical Stimulation Therapy for:

• Pressure ulcers, venous leg ulcers, and other hard-to-heal wounds

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Electrical stimulation (ES) has been shown to enhance the healing of pressure ulcers in spinal cord injury patients, with positive results reported in all 11 therapeutic studies included in the review of 27 studies.

Despite the promising effects of ES on pressure ulcer healing, the overall methodological quality of the studies was poor, and there was significant variability in ES parameters and techniques, making it difficult to recommend a standardized approach for treatment or prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. Liu, LQ., Moody, J., Traynor, M., et al.[2022]

Monophasic pulsed microcurrent stimulation at frequencies of 1 to 8 Hz significantly increased the number of human dermal fibroblasts in vitro, suggesting it could enhance wound healing for pressure injuries.

Stimulation at 64 Hz decreased cell numbers, indicating that lower frequencies (1-8 Hz) are optimal for promoting fibroblast growth and potentially accelerating the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monophasic Pulsed Microcurrent of 1-8 Hz Increases the Number of Human Dermal Fibroblasts. Yoshikawa, Y., Sugimoto, M., Uemura, M., et al.[2022]

Electrical stimulation (ES) significantly enhances the healing rates of pressure ulcers in individuals with spinal cord injuries, with a mean difference of 4.97 indicating improved outcomes compared to standard wound care.

Pulsed current ES was found to be more effective than constant current ES in promoting healing, suggesting that the type of electrical current and electrode placement can influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quantitative, Pooled Analysis and Systematic Review of Controlled Trials on the Impact of Electrical Stimulation Settings and Placement on Pressure Ulcer Healing Rates in Persons With Spinal Cord Injuries. Liu, L., Moody, J., Gall, A.[2018]

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]

Electrical stimulation (ES) has been studied for its potential to enhance the healing of chronic wounds, but not all forms of ES are effective; only specific protocols, like monophasic pulsed current and certain biphasic pulsed currents, have shown consistent positive results.

Recent advancements in ES technology, such as microcurrent devices used in wound dressings, have not yet demonstrated significant benefits in accelerating wound closure, highlighting the need for further research to establish effective treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials Involving Biphasic Pulsed Current, MicroCurrent, and/or Low-Intensity Direct Current. Houghton, PE.[2021]

Electrical stimulation (ES) has shown promise in enhancing the healing of chronic wounds, with clinical trials supporting its efficacy, yet it remains underutilized in the U.S. due to a lack of standardized protocols.

Despite the biological mechanisms indicating that wounds generate an endogenous electric field that promotes healing, inconsistencies in trial designs and application methods hinder the establishment of optimal ES treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Stimulation Therapy and Wound Healing: Where Are We Now? Isseroff, RR., Dahle, SE.[2021]

Electrical stimulation has a long history of use in medicine, and it shows great promise for treating various complications arising from spinal cord injuries, such as improving motor control and assisting with bodily functions.

Innovative applications of electrical stimulation are being explored for a wide range of functions in spinal cord injury patients, including enhancing cardiovascular fitness, aiding in breathing, and facilitating movement, which could significantly improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation in spinal cord injury. Sadowsky, CL.[2006]

Electrical stimulation therapy (EST) was found to be effective in treating complex acute and chronic wounds, with a 44.7% reduction in wound size and complete granulation in 30.4% of cases among 95 patients over an average of 48.1 days.

The therapy was well tolerated, with 77.2% of patients rating the treatment as good or very good, and only a few minor adverse events reported, indicating that EST is a safe option for wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, tolerability, and safety of electrical stimulation of wounds with an electrical stimulation device: results of a retrospective register study. Herberger, K., Debus, E., Larena-Avellaneda, A., et al.[2015]

Nanogenerator-driven electrostimulation (NG-ES) therapy significantly accelerates wound healing, achieving complete skin restoration within 7 days, compared to over 30 days reported in previous studies.

NG-ES enhances the inflammatory phase of healing by promoting faster resolution of immune cells and improving blood flow through increased neovascularization, indicating its potential for effective clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated complete human skin architecture restoration after wounding by nanogenerator-driven electrostimulation. Liu, A., Long, Y., Li, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949516/

Electrical stimulation therapy for the treatment of pressure ... EST appears to be an effective adjunctive therapy to accelerate and increase pressure ulcer closure in individuals with SCI. Keywords: Electrical stimulation ...

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05458947?draw=2&rank=1

Physical Therapy Wound Care Modalities in Patients With ... It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized ...

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

a novel therapeutic strategy to heal biological wounds The integration of electrical stimulation into clinical practice has the potential to revolutionize wound care and improve patient outcomes.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06088-0

Electrical stimulation to prevent recurring pressure ulcers in ... This study will assess if electrical stimulation is a (cost-)effective method to prevent PUs and reduce the risk factors of getting PUs.

6. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4352702/

Safety and Feasibility of Intermittent Electrical Stimulation ... Objective: To investigate the safety, feasibility, and acceptability of a novel treatment, intermittent electrical stimulation (IES), for preventing deep tissue ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05669508

Wearable Electrical Stimulation on the Back to Modulate ... The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and ...