Spinal Cord Injuries(SCI)NCT05458947
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
A study testing pulsed wound irrigation (PWI), electrical stimulation (ES) and electrical stimulation (ES) and pulsed wound irrigation (PWI) in people with Spinal Cord Injuries and Pressure Injuries, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Pressure Injuries
- What is being tested?
- pulsed wound irrigation (PWI), electrical stimulation (ES) and electrical stimulation (ES) and pulsed wound irrigation (PWI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carolinas Rehabilitation
Charlotte, North Carolina, 28203
About this study
Official title: 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).
Read the 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.
- Conditions
- Spinal Cord Injuries, Pressure Injuries
- Being tested
- pulsed wound irrigation (PWI), electrical stimulation (ES), electrical stimulation (ES) and pulsed wound irrigation (PWI)
- Keywords
- Wound Care, Physical Therapy, Pulsed wound irrigation, Electrical stimulation
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed wound irrigation (PWI)Procedure or surgery
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 or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| pulsed wound irrigation (PWI) | Experimental | 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 Receives: Procedure: pulsed wound irrigation (PWI) |
| electrical stimulation (ES) | Experimental | 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 Receives: Procedure: electrical stimulation (ES) |
| electrical stimulation (ES) and pulsed wound irrigation (PWI) | Experimental | 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 Receives: Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Year 1
Secondary outcomes (1)
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
Measured: Baseline and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start11 Oct 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Weeks, PT,DPT, CWS, Principal investigator, Carolinas Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458947
- Sponsor's protocol ID
- IRB00085228
- Acronym
- (SCI)
- Status last verified
- Apr 2026
- First submitted
- 6 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05458947
- Acronym / sponsor ID
- (SCI) / IRB00085228
- Conditions
- Spinal Cord Injuries, Pressure Injuries
- Keywords
- Wound Care, Physical Therapy, Pulsed wound irrigation, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| pulsed wound irrigation (PWI) | Experimental | Procedure: 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 |
| electrical stimulation (ES) | Experimental | Procedure: 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 |
| electrical stimulation (ES) and pulsed wound irrigation (PWI) | Experimental | Procedure: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | pulsed wound irrigation (PWI) |
| 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 | Procedure or surgery | electrical stimulation (ES) |
| 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 | Procedure or surgery | electrical stimulation (ES) and pulsed wound irrigation (PWI) |
Primary outcome
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
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
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
1 secondary outcome
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
Time frame: Baseline and Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Weeks, PT,DPT, CWS principal investigator
Carolinas Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed wound irrigation (PWI), electrical stimulation (ES) and electrical stimulation (ES) and pulsed wound irrigation (PWI) in people with Spinal Cord Injuries and Pressure Injuries, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Weeks, PT, DPT,WS (704-355-4461, Erin.Weeks@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bates-Jensen Wound Assessment Tool (BWAT) score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.