NCT06813430

Non-Contact Low-Frequency Ultrasound Vs Standard LaLonde Protocol for Fingertip Injury Wound Healing

Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: St. Luke's Hospital, Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy of non-contact low frequency ultrasound in populations sustaining fingertip amputations. The main question it aims to answer is: • Does non-contact low frequency ultrasound significantly improve patient outcomes in patients sustaining acute fingertip amputations? Researchers will compare non-contact low frequency ultrasound to a standard Lalonde protocol to answer this questions. Participants will be randomized one of the two study arms and evaluated by wound care therapy. They will receive cohort appropriate therapy sessions 2-3 times per week with measurement of wound size once per week.

Detailed description

Fingertip injuries rank among the most prevalent hand injuries, leading to nearly 5 million emergency department visits annually. Particularly common among adults, are lacerations, crush injuries, and avulsions affecting the thumb, index finger, and middle finger. As fingertip amputations encompass a diverse range of injuries involving soft tissue, bone, and/or nail, there is no singular recommended treatment as the standard of care. Instead, treatment is tailored to the individual patient, aiming to minimize pain, optimize healing, preserve sensory and motor function, and maintain an aesthetically acceptable appearance. Possible treatment options for fingertip amputations without exposure of the distal phalanx include primary closure, healing by secondary intention, completion/revision amputation, full-thickness skin grafting, and split-thickness skin grafting, or flap coverage. However, when soft tissue allows, primary closure or healing by secondary intention have demonstrate positive and reliable outcomes. New technologies, such as non-contact low-frequency ultrasound (NCLF-US), continue to be introduced to support healing of acute and chronic injuries to improve patient outcomes. While a moderate amount of research exists demonstrating safety and efficacy of NCLF-US in expediting the healing of chronic wounds, there is limited research on its efficacy in the treatment of acute injuries. Given the significance of optimizing healing, especially in a population predominantly composed of young men engaged in manual labor, it is reasonable to wonder about the efficacy of NCLF-US in the treatment of fingertip amputations without exposed bone managed through secondary intention. This study aimed to compare the efficacy of NCLF-US in combination with standard treatment for secondary healing versus the standard treatment alone.

Conditions

• Non-contact Low Frequency Ultrasound
• Lalonde Protocol
• Fingertip Amputation

Interventions

Type	Name	Description
DEVICE	Non-contact Low Frequency Ultrasound	NCLF-US therapy involves delivering low-frequency (40 kHz), low-intensity (0.1-0.8 W/cm2) ultrasound energy via sterile water mist.
OTHER	Lalonde Protocol (standard of care)	Standard of care local wound therapy using the Lalonde protocol - rinsing the site with clean water, applying a grease layer, wrapping with a one-inch gauze wrap, and securing with Coban tape.

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-02-07
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study