An interventional study of pulsed wound irrigation (PWI) and electrical stimulation (ES) in Spinal Cord Injuries and Pressure Injuries, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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).
It is hypothesized that PWI + ES will demonstrate the greatest rate of wound healing due to the combined effect of these treatments, which positively impact several aspects of the wound healing cascade. It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized education and treatments which engage patients in their wound healing process and promote self-efficacy.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: pulsed wound irrigation (PWI)
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
Procedure: electrical stimulation (ES)
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
Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)
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
high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes
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 high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes
Bates-Jensen Wound Assessment Tool (BWAT) score
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
Time frame: Baseline
Bates-Jensen Wound Assessment Tool (BWAT) score
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
Time frame: Week 1
Bates-Jensen Wound Assessment Tool (BWAT) score
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
Time frame: Year 1
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
measures health-related quality of life specific to patients with Spinal Cord Injuries (SCI) - Higher scores indicate worse functioning quality of life related to pressure injuries, while lower scores indicate fewer impairments
Time frame: Baseline and Year 1
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Jan 2027, 51 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 51 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion Oct 2026 → Jan 2027 and completion Oct 2026 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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