Ultrasound Treatment on Wound Healing Time (NCT05796492) | Clinical Trial Compass
TerminatedNot Applicable
Ultrasound Treatment on Wound Healing Time
Stopped: recruitment/ enrollment issues
United States8 participantsStarted 2023-06-22
Plain-language summary
This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female aged 18 or older
* Second-degree burn wounds of less than 20% total body surface area (TBSA)
* No active wound infection at screening based on clinical criteria
* Able to provide written informed consent
Exclusion Criteria:
* Wounds determined by study clinicians to be ineligible, including those that may inhibit access to the spleen for the ultrasound procedure
* Participating in another research study that may affect the conduct of results of this study
* BMI \> 30
* Having or exhibiting any of the following:
* Previous surgery of the spleen, esophagus, stomach, duodenum, or liver, including splenectomy
* End stage renal disease and/or uremia
* Active malignancy
* Previous leukemia and/or lymphoma
* Human immunodeficiency virus infection or AIDS
* Rheumatoid arthritis or other immune-mediated diseases (e.g., inflammatory bowel disease
* Arrythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block
* Implanted pacemaker or cardioverter/debribrillator
* History of unstable angina, angioplasty or coronary arterial by-pass grafting surgery
* History of stroke or TIA
* Untreated thrombosis or bleeding disorders
* Currently implanted vagus nerve stimulator
* Currently implanted spinal cord stimulator or other chronically implanted electronic device
* Receiving oral, topical, rectal, or parenteral corticosteroids in an unsta…
What they're measuring
1
Incidence and severity of adverse device effects (ADEs)
Timeframe: Days 1 -28
2
Median time to re-epithelialization using advanced digital imaging
Timeframe: 28 days or until healed (whichever comes first)