Recruiting

PWI, ES, PT

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05458947

Conditions

Spinal Cord Injuries

Pressure Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pulsed wound irrigation (PWI)

electrical stimulation (ES)

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

Study Details

Brief summary:

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).

Conditions

Spinal Cord Injuries

Pressure Injuries

Study ID

NCT05458947

Start date

Oct 11, 2022

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Currently enrolled at inpatient rehabilitation at Carolinas Rehabilitation Charlotte
  • Diagnosis of spinal cord injury and concomitant pressure injury to sacrum or ischium
  • Agreeable to wound care treatment by Physical Therapist (PT)
  • Able to perform informed consent
  • Over 18 years of age
  • Physician order for PT wound care evaluation and treatment
  • Bates-Jensen Wound Assessment Tool (BWAT) >31 on initial evaluation

Exclusion Criteria:

  • Pain which limits ability to tolerate wound care treatments
  • Unable to perform informed consent
  • Pregnancy
  • Bates-Jensen Wound Assessment Tool (BWAT) <30 on initial evaluation

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: pulsed wound irrigation (PWI)

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

experimental: electrical stimulation (ES)

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

experimental: electrical stimulation (ES) and pulsed wound irrigation (PWI)

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

Interventions

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

electrical stimulation (ES)

high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes

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 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

Primary outcome measure

  • Bates-Jensen Wound Assessment Tool (BWAT) score [ Time Frame: Baseline ]
  • Bates-Jensen Wound Assessment Tool (BWAT) score [ Time Frame: Week 1 ]
  • Bates-Jensen Wound Assessment Tool (BWAT) score [ Time Frame: Year 1 ]

Central Contacts and Locations

Central contacts

Erin Weeks, PT, DPT,WS

704-355-4461Erin.Weeks@advocatehealth.org

Locations

Carolinas Rehabilitation

Recruiting

Charlotte, North Carolina, United States, 28203

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Wound Care
  • Physical Therapy
  • Pulsed wound irrigation
  • Electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-08.