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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bates-Jensen Wound Assessment Tool (BWAT) score

Secondary study objectives

Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out