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Ultrasound Therapy

LOGIQ E10 ultrasound Active for Burns (GE-MTEC Trial)

N/A

Recruiting

Led By David Armstrong, DPM, MD, PhD

Research Sponsored by General Electric Research

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 days 7, 14, 21 and 28

Awards & highlights

GE-MTEC Trial Summary

This trial will test if ultrasound can help heal burn wounds faster. 24 people will be involved and randomly assigned to either active or sham ultrasound.

Who is the study for?

Adults aged 18+ with second-degree burns covering less than 20% of their body, who can consent to the study. They must not have an active wound infection or a high BMI (>30), and should not have had certain surgeries or conditions affecting the spleen, heart, blood, immune system; nor be on unstable steroids, other studies that could interfere, or have recent substance abuse.Check my eligibility

What is being tested?

The trial is testing if pulsed ultrasound focused on the spleen can speed up healing in burn wounds. It's a small-scale study with half of the participants receiving real ultrasound treatment and half getting sham (fake) treatment to compare outcomes.See study design

What are the potential side effects?

Since this is a pilot study primarily assessing safety and feasibility, detailed side effects are not provided but may include discomfort at the site of ultrasound application or potential unknown risks related to novel use of this technology.

GE-MTEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 7, 14, 21 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 7, 14, 21 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7, 14, 21 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of adverse device effects (ADEs)

Median time to re-epithelialization using advanced digital imaging

Secondary outcome measures

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

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

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

+4 more

GE-MTEC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: LOGIQ E10 ultrasound ActiveActive Control1 Intervention

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

Group II: LOGIQ E10 ShamPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

General Electric ResearchLead Sponsor

2 Previous Clinical Trials

46 Total Patients Enrolled

David Armstrong, DPM, MD, PhDPrincipal InvestigatorUSC Limb Preservation Consortium

6 Previous Clinical Trials

531 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still actively seeking participants for this investigation?

"According to clinicaltrials.gov, this medical study is no longer open for enrollment. It was initially posted on April 15th 2023 and last updated March 30th 2023. Although this trial has since closed, there are currently 842 trials actively accepting patients at the present time."

Answered by AI

What are the foremost goals of this research initiative?

"According to the study sponsor, General Electric Research, the primary outcome is Median time to re-epithelialization via advanced digital imaging over Days 1 - 28. Additionally, Secondary outcomes are Difference in groups' itch measured on a VAS scale from 0-10 (with 10 being worst), Difference of non-invasive perfusion gauged with a VAS score ranging 0 - 10 (again with 10 representing worse outcomes) and finally Referral to Scar Management Specialists for evaluation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultrasound Treatment on Wound Healing Time

2023. "Ultrasound Treatment on Wound Healing Time". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796492.