What is the mechanism of action of this treatment?

Common treatments for burns often focus on modulating the immune response and reducing inflammation to promote wound healing. For instance, Splenic Focused Pulsed Ultrasound Treatment aims to enhance wound healing by modulating the immune response and reducing inflammation, which can accelerate tissue repair and reduce scarring. This is crucial for burn patients as it can lead to faster recovery, reduced risk of infection, and improved functional and cosmetic outcomes. Other treatments, such as topical antimicrobials and dressings, work by preventing infection and maintaining a moist wound environment, which also supports the body's natural healing processes.

What side effects are associated with this type of intervention?

Common treatments for burns, including ultrasound therapy, can cause mild discomfort, skin irritation, or a sensation of warmth. Topical antibiotics and dressings may lead to allergic reactions, skin irritation, or infection. More invasive treatments like skin grafts can result in scarring, infection, and graft rejection.

What prior FDA approvals exist?

FDA-approved treatments for burns primarily focus on wound care, infection prevention, and pain management. While specific approvals for splenic focused pulsed ultrasound treatment are not mentioned, other treatments that modulate immune response and inflammation include topical agents like silver sulfadiazine and systemic therapies such as corticosteroids. These treatments aim to reduce inflammation, prevent infection, and promote healing. Advanced therapies like biologic dressings and skin substitutes also play a role in managing severe burns by providing a scaffold for new tissue growth and modulating the local immune response.

What other types of research exist?

Promising novel alternatives for burn patients in 2024 include: 1) Platelet-rich plasma (PRP) injections, which contain growth factors that stimulate tissue repair. 2) Integrative therapies such as acupuncture, yoga, and mindfulness-based practices, which can help manage pain and inflammation. 3) Advanced laser and light therapies, which have been effective in treating various skin conditions and promoting healing. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Ultrasound Therapy

Ultrasound Treatment 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

Summary

This trial is testing if using sound waves on the spleen can help heal burn wounds faster in patients with smaller burns. The sound waves are thought to reduce inflammation and improve immune cell function, speeding up recovery.

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.

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.

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.

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

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

Primary study objectives

Incidence and severity of adverse device effects (ADEs)

Median time to re-epithelialization using advanced digital imaging

Secondary study objectives

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burns often focus on modulating the immune response and reducing inflammation to promote wound healing. For instance, Splenic Focused Pulsed Ultrasound Treatment aims to enhance wound healing by modulating the immune response and reducing inflammation, which can accelerate tissue repair and reduce scarring. This is crucial for burn patients as it can lead to faster recovery, reduced risk of infection, and improved functional and cosmetic outcomes. Other treatments, such as topical antimicrobials and dressings, work by preventing infection and maintaining a moist wound environment, which also supports the body's natural healing processes.