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

NCT ID: NCT05458947

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries Pressure Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pulsed wound irrigation (PWI)

Intervention Type 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)

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

Group Type EXPERIMENTAL

electrical stimulation (ES)

Intervention Type 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)

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type 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 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Weeks, PT,DPT, CWS

Role: PRINCIPAL_INVESTIGATOR

Carolinas Rehabilitation

Locations

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Carolinas Rehabilitation

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Weeks, PT, DPT,WS

Role: CONTACT

704-355-4461

Other Identifiers

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IRB00085228

Identifier Type: -

Identifier Source: org_study_id

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