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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05458947
Acronym
(SCI)
Enrollment
40
Registered
2022-07-14
Start date
2022-10-11
Completion date
2026-10-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injuries, Spinal Cord Injuries

Keywords

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

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).

Detailed description

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.

Interventions

PROCEDUREpulsed 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

PROCEDUREelectrical 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

PROCEDUREelectrical 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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

To examine the effects of PT wound care modalities (PWI + ES, PWI only, and ES only) on wound healing in patients with SCI

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bates-Jensen Wound Assessment Tool (BWAT) scoreBaseline15-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

MeasureTime frameDescription
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form ScoreBaseline and Year 1measures 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

Countries

United States

Contacts

CONTACTErin Weeks, PT, DPT,WS
Erin.Weeks@advocatehealth.org704-355-4461
PRINCIPAL_INVESTIGATORErin Weeks, PT,DPT, CWS

Carolinas Rehabilitation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026