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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Non-contact Low Frequency Ultrasound — DEVICE
  NCLF-US therapy involves delivering low-frequency (40 kHz), low-intensity (0.1-0.8 W/cm2) ultrasound energy via sterile water mist.
• Lalonde Protocol (standard of care) — OTHER
  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.

Study Details

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.

Key Dates

Start date

Feb 10, 2025

Status verified

May 2025

Primary completion

Feb 28, 2026

Completion

Feb 28, 2026

Study Design

Enrollment

22 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Wound Dimensions (mm2) [ Time Frame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks) ]

Central Contacts

• Kristofer Matullo, MD
  484-526-1735
  [email protected]
• Douglas Lundy, MD
  [email protected]

Locations (1)

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