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
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedStudy Start
First participant enrolled
October 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 8, 2026
April 1, 2026
4 years
July 6, 2022
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
Baseline and Year 1
Study Arms (3)
pulsed wound irrigation (PWI)
EXPERIMENTALThe 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)
EXPERIMENTALES 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
electrical stimulation (ES) and pulsed wound irrigation (PWI)
EXPERIMENTALThe 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
Interventions
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
high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Rehabilitation
Charlotte, North Carolina, 28203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Weeks, PT,DPT, CWS
Carolinas Rehabilitation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 14, 2022
Study Start
October 11, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share