RecruitingNot ApplicableNCT06813430

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


Sponsor

St. Luke's Hospital, Pennsylvania

Enrollment

22 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria7

  • 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

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Interventions

DEVICENon-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.

OTHERLalonde 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.


Locations(1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

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NCT06813430