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NCT Number: NCT05458947

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

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).

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Pressure Injuries Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Bates-Jensen Wound Assessment Tool (BWAT) score

    Time frame: Baseline

    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

  2. Bates-Jensen Wound Assessment Tool (BWAT) score

    Time frame: Week 1

    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

  3. Bates-Jensen Wound Assessment Tool (BWAT) score

    Time frame: Year 1

    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

Secondary outcomes

  1. Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score

    Time frame: Baseline and Year 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Weeks, PT, DPT,WS

CONTACT

[email protected]

704-355-4461

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury

Acronym: (SCI)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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