Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05458947
Status
Recruiting
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Conditions

  • Pressure Injuries
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pulsed wound irrigation (PWI) — PROCEDURE
    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) — PROCEDURE
    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) — PROCEDURE
    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

Study Details

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).

Key Dates

Start date
Oct 11, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolinas RehabilitationCharlotteNorth Carolina28203-

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By research site
Carolinas Rehabilitation· Charlotte, NC

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