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

St. Luke's Hospital, Pennsylvania

Status: Enrolling

Conditions: Fingertip Amputation; Non-contact Low Frequency Ultrasound; Lalonde Protocol

Treatments: Device: Non-contact Low Frequency Ultrasound; Other: Lalonde Protocol (standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT06813430

FY2025-115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 18 years or older with an acute traumatic fingertip amputation without exposed bone or tendons (Allen 1, Tamai level 1; ICD-10 codes S68.5 and S68.6).

Exclusion criteria

• Patients less than 18 years old,
• Injuries involving exposed bone
• Those with diagnosis of vascular disease
• Individuals with clinical suspicion or diagnosis of infection
• Unable to comply with prescribed therapy sessions
• Patients undergoing primary closure or surgical intervention
• Patients experiencing subsequent trauma following treatment initiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Non-Contact Low Frequency Ultrasound

Experimental group

Description:

Lalonde therapy and non-contact low-frequency (UltraMIST) therapy - NCLF-US therapy involves delivering low-frequency (40 kHz), low-intensity (0.1-0.8 W/cm2) ultrasound energy via sterile water mist.

Treatment:

Other: Lalonde Protocol (standard of care)

Device: Non-contact Low Frequency Ultrasound

Lalonde Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Lalonde Protocol (standard of care)