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

Phase

N/A

Condition

N/A

Treatment

Non-contact Low Frequency Ultrasound

Lalonde Protocol (standard of care)

Clinical Study ID

NCT06813430

FY2025-115

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals aged 18 years or older with an acute traumatic fingertip amputationwithout exposed bone or tendons (Allen 1, Tamai level 1; ICD-10 codes S68.5 andS68.6).

Exclusion

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

Study Design

Non-contact Low Frequency Ultrasound

February 10, 2025

February 28, 2026

Study 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.

Connect with a study center

St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
Active - Recruiting

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