40 Participants Needed

PWI + ES for Spinal Cord Injury Wound Care

((SCI) Trial)

EW
Overseen ByErin Weeks, PT, DPT,WS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).

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 electrical stimulation therapy safe for wound care?

Research indicates that electrical stimulation therapy (ES) for wound care is generally safe for humans, as studies have focused on its effectiveness and tolerability in treating wounds under various conditions.12345

How does the PWI + ES treatment for spinal cord injury wound care differ from other treatments?

The PWI + ES treatment is unique because it combines electrical stimulation (ES) with pulsed wound irrigation (PWI) to promote wound healing in spinal cord injury patients. This approach uses electrical currents to mimic the body's natural healing processes and has shown promise in increasing the healing rate of pressure ulcers, which are common in these patients.16789

What data supports the effectiveness of the treatment PWI + ES for Spinal Cord Injury Wound Care?

Research shows that certain forms of electrical stimulation (ES), like monophasic pulsed current, have been effective in speeding up the healing of chronic wounds. Additionally, ES has shown benefits in preventing and treating pressure ulcers in people with spinal cord injuries.13567

Who Is on the Research Team?

EW

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.
See 4 more

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
See 1 more

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?
3Treatment groups
Experimental Treatment
Group I: pulsed wound irrigation (PWI)Experimental Treatment1 Intervention
Group II: electrical stimulation (ES) and pulsed wound irrigation (PWI)Experimental Treatment1 Intervention
Group III: electrical stimulation (ES)Experimental Treatment1 Intervention

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

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Approved in Canada as Electrical Stimulation Therapy for:
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Approved in European Union as Electrical Stimulation Therapy for:
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Approved in United States as Electrical Stimulation Therapy for:

Find a Clinic Near You

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

Citations

A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. [2022]
Monophasic Pulsed Microcurrent of 1-8 Hz Increases the Number of Human Dermal Fibroblasts. [2022]
Clinical Trials Involving Biphasic Pulsed Current, MicroCurrent, and/or Low-Intensity Direct Current. [2021]
A Quasi-Experimental Evaluation of an Education Program for the Use of Electrical Stimulation Therapy to Heal Pressure Injuries. [2021]
Electrical Stimulation Therapy and Wound Healing: Where Are We Now? [2021]
Effectiveness, tolerability, and safety of electrical stimulation of wounds with an electrical stimulation device: results of a retrospective register study. [2015]
Accelerated complete human skin architecture restoration after wounding by nanogenerator-driven electrostimulation. [2022]
Electrical stimulation in spinal cord injury. [2006]
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. [2018]
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