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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Pressure Injuries
• Intervention / Treatment: Procedure: pulsed wound irrigation (PWI); Procedure: electrical stimulation (ES); Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Weeks, PT, DPT,WS; Phone Number: 704-355-4461; Email: Erin.Weeks@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Carolinas Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: 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
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bates-Jensen Wound Assessment Tool (BWAT) score	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	Baseline
Bates-Jensen Wound Assessment Tool (BWAT) score	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	Week 1
Bates-Jensen Wound Assessment Tool (BWAT) score	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	Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score	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	Baseline and Year 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Erin Weeks, PT,DPT, CWS, Carolinas Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical Therapy; Electrical stimulation; Wound Care; Pulsed wound irrigation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Skin Diseases; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Skin and Connective Tissue Diseases; Spinal Cord Injuries; Pressure Ulcer; Investigative Techniques; Physical Stimulation; Electric Stimulation
• Other Study ID Numbers: IRB00085228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No