Recruiting

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

Sponsor:

St. Luke's Hospital, Pennsylvania

Code:

NCT06813430

Conditions

Non-contact Low Frequency Ultrasound

Lalonde Protocol

Fingertip Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-contact Low Frequency Ultrasound

Lalonde Protocol (standard of care)

Study Details

Brief 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

Study ID

NCT06813430

Start date

Feb 10, 2025

Status verified date

May, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

Wound Dimensions (mm2) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Kristofer Matullo, MD

484-526-1735 Kristofer.Matullo@sluhn.org

Douglas Lundy, MD

douglas.lundy@sluhn.org

Locations

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Kristofer Matullo, MD

484-526-1735 Kristofer.Matullo@sluhn.org

Principal Investigator:

Kristofer Matullo, MD

More Information

Sponsor

St. Luke's Hospital, Pennsylvania

Last update posted

May 15, 2025

Last verified

May, 2025

Keywords

non-contact low frequency ultrasound
Lalonde protocol
fingertip amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Luke's Hospital, Pennsylvania on 2025-05-15.