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

NCT06813430 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • St. Luke's Hospital, Pennsylvania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813430 on ClinicalTrials.gov