Ultrasound Treatment on Wound Healing Time

NCT05796492 | Terminated FDA Device

• 1 other identifier: HS-22-00019
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Burn Wound; 2nd Degree Burn of the Skin

Outcome Measures

Primary Outcomes (2)

• 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.

  Days 1 -28

• Median time to re-epithelialization using advanced digital imaging

  Re-epithelialization measured by digital planimetry

  28 days or until healed (whichever comes first)

Secondary Outcomes (7)

• Difference in groups in pain measured visual analog scale, (VAS)

  Days 7, 14, 21 and 28

• Difference in groups in itch measured visual analog scale, (VAS)

  Days 7, 14, 21 and 28

• Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)

  Days 7, 14, 21 and 28

• Referral to scar management specialist

  Days 7, 14, 21 and 28

• Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)

  Days 7, 14, 21 and 28

Study Arms (2)

LOGIQ E10 Sham

SHAM COMPARATOR

The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.

Device: Ultrasound probe (no energy applied)

LOGIQ E10 ultrasound Active

ACTIVE COMPARATOR

The intervention condition will receive 10 minutes of splenic ultrasound daily.

Device: Pulsed splenic ultrasound

Interventions

Pulsed splenic ultrasound DEVICE

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.

Also known as: Active ultrasound

LOGIQ E10 ultrasound Active

Ultrasound probe (no energy applied) DEVICE

A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied

LOGIQ E10 Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Electric Research: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• David Armstrong, DPM, MD, PhD

  USC Limb Preservation Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: April 3, 2023
• Study Start: June 22, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 19, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

US (1)