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PWI + ES for Spinal Cord Injury Wound Care ((SCI) Trial)
N/A
Recruiting
Led By Erin Weeks, PT,DPT, CWS
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
(SCI) Trial Summary
This trial looks at whether adding electrical stimulation to pulsed wound irrigation helps heal wounds better in people with spinal cord injuries.
Who is the study for?
This trial is for adults over 18 with spinal cord injuries and pressure sores on the lower back or hip, who are inpatient at Carolinas Rehabilitation Charlotte. They must be able to consent to treatment and have a wound severity score above 31. People can't join if they're pregnant, can't tolerate pain from treatments, cannot consent, or have less severe wounds.Check my eligibility
What is being tested?
The study tests how well different physical therapy techniques help heal wounds in spinal cord injury patients. It compares pulsed wound irrigation (PWI), electrical stimulation (ES), and their combination to see which is most effective.See study design
What are the potential side effects?
Possible side effects may include discomfort during treatment sessions due to electrical stimulation or the irrigation process. Pain levels might limit some patients' ability to continue with certain treatments.
(SCI) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bates-Jensen Wound Assessment Tool (BWAT) score
Secondary outcome measures
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
(SCI) Trial Design
3Treatment groups
Experimental Treatment
Group I: pulsed wound irrigation (PWI)Experimental Treatment1 Intervention
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 II: electrical stimulation (ES) and pulsed wound irrigation (PWI)Experimental Treatment1 Intervention
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 III: electrical stimulation (ES)Experimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,215 Total Patients Enrolled
Erin Weeks, PT,DPT, CWSPrincipal InvestigatorCarolinas Rehabilitation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or sign the consent form by myself.I am over 18 years old.My doctor has ordered physical therapy for my wound care.My pain stops me from handling wound care well.I am willing to have a physical therapist treat my wound.I have a spinal cord injury and a pressure sore on my lower back or buttocks.
Research Study Groups:
This trial has the following groups:- Group 1: pulsed wound irrigation (PWI)
- Group 2: electrical stimulation (ES)
- Group 3: electrical stimulation (ES) and pulsed wound irrigation (PWI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment in need of additional participants?
"Affirmative, the trial is actively recruiting as per information on clinicaltrials.gov. This research study was first announced on October 11th 2022 and has recently been updated with the same date. 40 volunteers are needed from a single location to participate in this medical experiment."
Answered by AI
What is the current count of participants in this experiment?
"Yes, the details posted to clinicaltrials.gov confirm that this medical trial is now open for enrolment. The initial posting date was October 11th 2022 and it has since been reviewed on the same day. Recruiters are targeting 40 volunteers at a single location."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Carolinas Rehabilitation
What portion of applicants met pre-screening criteria?
Met criteria
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