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

May 12, 2025 updated by: St. Luke's Hospital, Pennsylvania

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health network
        • Contact:
        • Principal Investigator:
          • Kristofer Matullo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Contact Low Frequency Ultrasound
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.
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.
Active Comparator: Lalonde Protocol
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Dimensions (mm2)
Time Frame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
Would dimensions will be measured in two dimensions using a ruler and recorded.
Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
Time to Healing (days)
Time Frame: From randomization through study completion (an average of 8 weeks)
Time to healing will be determined in days from randomization through study completion. This will vary between groups, but is expected to be complete by 8 weeks for all patients.
From randomization through study completion (an average of 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Pain (Visual Analog Scale)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
The Visual Analog Scale, or VAS, will be used to measure subjective pain. Patients will report subjective pain on a scale of 1-10 with 10 indicating worse pain.
Assessed weekly. From randomization through study completion (an average of 8 weeks)
2 point discrimination (mm)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Calipers will be used to determine patient 2-point discrimination status. A healthy patient is able to report discrimination between two points at 2-8mm at the fingertips. Larger values indicate worsening discrimination between two points and indicate worsening neurologic status.
Assessed weekly. From randomization through study completion (an average of 8 weeks)
Semmes Weinstein (Monofilament Sensitivity Test)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
A monofilament will be used to determine sensory status in the affected finger. Patients report yes or no when asked if they can sense the monofilament.
Assessed weekly. From randomization through study completion (an average of 8 weeks)
Grip Strength (lbs)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
A handgrip dynamometer will be used to determine the handgrip strength for patients in lbs. Larger numbers indicate increased strength.
Assessed weekly. From randomization through study completion (an average of 8 weeks)
Pinch Strength (lbs)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
A pinch dynamometer will be used to determine the pinch strength for patients in lbs. Larger numbers indicate increased strength.
Assessed weekly. From randomization through study completion (an average of 8 weeks)
Number of Visits (n)
Time Frame: From randomization through study completion (an average of 8 weeks)
The number of visits the patient attends will be recorded. It is expected that patient enrollment in the study will be complete by an average of 8 weeks.
From randomization through study completion (an average of 8 weeks)
Functional Scores (Quick Disabilities of Arm, Shoulder, Hand)
Time Frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
The Quick Disabilities of Arm, Shoulder, Hand (QuickDASH), a validating instrument, will be used to assess patient functional status. Scores range from 0-100. Higher scores indicate worse functional status.
Assessed weekly. From randomization through study completion (an average of 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FY2025-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In order to comply with the Health Insurance Portability and Accountability Act (HIPPA) as well as local/institutional regulations, only deidentified data can be provided from the primary investigator upon reasonable request. Independent review of the deidentified data to verify its accuracy will be permitted after article publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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