Back to resultsUltrasound Treatment on Wound Healing Time (GE-MTEC)
Primary Purpose
Burn Wound, 2nd Degree Burn of the Skin
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed splenic ultrasound
Ultrasound probe (no energy applied)
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wound
Eligibility Criteria
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 unstable dose 4 weeks prior to baseline visit Any immunosuppressive or cytotoxic medications Clinically relevant history of alcohol or drug abuse as determined by the investigator including: alcohol consumption within 4 days of the baseline visit tobacco or nicotine product use within the past 1 month recreational drug use within the past 1 month Pregnant or breast feeding Unable or unwilling to comply with study procedures Have recently (within 3 months) been diagnosed with COVID, or have ever been diagnosed with long COVID Have an autoimmune disorder, such as, rheumatoid arthritis or lupus
Sites / Locations
- LAC+USC Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
LOGIQ E10 Sham
LOGIQ E10 ultrasound Active
Arm Description
The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.
The intervention condition will receive 10 minutes of splenic ultrasound daily.
Outcomes
Primary Outcome Measures
Incidence and severity of adverse device effects (ADEs)
Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover <20% body surface area.
Median time to re-epithelialization using advanced digital imaging
Re-epithelialization measured by digital planimetry
Secondary Outcome Measures
Difference in groups in pain measured visual analog scale, (VAS)
Pain, scale 0-10 with 10 being worst outcome
Difference in groups in itch measured visual analog scale, (VAS)
Itch, scale 0-10 with 10 being worst outcome
Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)
Doppler perfusion, scale 0-10 with 10 being worst outcome
Referral to scar management specialist
Scar management
Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)
A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation).
Multiplexed analysis of plasma levels of inflammatory cytokines
Plasma levels of inflammatory cytokines, lab range values
Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations
Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05796492
Brief Title
Ultrasound Treatment on Wound Healing Time
Acronym
GE-MTEC
Official Title
Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 22, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Electric Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
The Central Hypothesis underlying this study is that splenic ultrasound stimulation activates the splenic anti-inflammatory pathway, thereby producing reduction in circulating macrophage cytokine production, reduction of neutrophil invasiveness, or induction of phenotypic transition in circulating immune cells (e.g., M1 to M2 transition in macrophages) in patients with partial thickness wounds that cover <20% body surface area.
Approximately 24 subjects will participate in this study. Male and female subjects of all races and ethnicities will be recruited for study from the ethnically diverse patient population of the LAC+USC Burn Center from the surrounding area.
Phase 0
Burn wound subjects will be screened and enrolled at the LAC+USC Burn Center located in Los Angeles, California. No other sites, neither regional nor outside of the United States are going to participate in enrollment of subjects.
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
12 months.
28 days or until healed (whichever comes first)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound, 2nd Degree Burn of the Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LOGIQ E10 Sham
Arm Type
Sham Comparator
Arm Description
The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.
Arm Title
LOGIQ E10 ultrasound Active
Arm Type
Active Comparator
Arm Description
The intervention condition will receive 10 minutes of splenic ultrasound daily.
Intervention Type
Device
Intervention Name(s)
Pulsed splenic ultrasound
Other Intervention Name(s)
Active ultrasound
Intervention Description
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
Intervention Type
Device
Intervention Name(s)
Ultrasound probe (no energy applied)
Intervention Description
A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied
Primary Outcome Measure Information:
Title
Incidence and severity of adverse device effects (ADEs)
Description
Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover <20% body surface area.
Time Frame
Days 1 -28
Title
Median time to re-epithelialization using advanced digital imaging
Description
Re-epithelialization measured by digital planimetry
Time Frame
28 days or until healed (whichever comes first)
Secondary Outcome Measure Information:
Title
Difference in groups in pain measured visual analog scale, (VAS)
Description
Pain, scale 0-10 with 10 being worst outcome
Time Frame
Days 7, 14, 21 and 28
Title
Difference in groups in itch measured visual analog scale, (VAS)
Description
Itch, scale 0-10 with 10 being worst outcome
Time Frame
Days 7, 14, 21 and 28
Title
Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)
Description
Doppler perfusion, scale 0-10 with 10 being worst outcome
Time Frame
Days 7, 14, 21 and 28
Title
Referral to scar management specialist
Description
Scar management
Time Frame
Days 7, 14, 21 and 28
Title
Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)
Description
A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation).
Time Frame
Days 7, 14, 21 and 28
Title
Multiplexed analysis of plasma levels of inflammatory cytokines
Description
Plasma levels of inflammatory cytokines, lab range values
Time Frame
Days 7, 14, 21 and 28
Title
Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations
Description
Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values
Time Frame
Days 7, 14, 21 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 unstable dose 4 weeks prior to baseline visit
Any immunosuppressive or cytotoxic medications
Clinically relevant history of alcohol or drug abuse as determined by the investigator including:
alcohol consumption within 4 days of the baseline visit
tobacco or nicotine product use within the past 1 month
recreational drug use within the past 1 month
Pregnant or breast feeding
Unable or unwilling to comply with study procedures
Have recently (within 3 months) been diagnosed with COVID, or have ever been diagnosed with long COVID
Have an autoimmune disorder, such as, rheumatoid arthritis or lupus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabiola Guadalupe Rodriguez
Phone
(323) 516-2132
Email
fabiola.rodriguez@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Armstrong, DPM, MD, PhD
Organizational Affiliation
USC Limb Preservation Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elia Salazar Plascencia
First Name & Middle Initial & Last Name & Degree
Jason Garcia
First Name & Middle Initial & Last Name & Degree
David G Armstrong, DPM, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Treatment on Wound Healing Time
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