An interventional study of Non-contact Low Frequency Ultrasound and Lalonde Protocol (standard of care) in Non-contact Low Frequency Ultrasound, Lalonde Protocol and Fingertip Amputation, sponsored by St. Luke's Hospital, Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by St. Luke's Hospital, Pennsylvania · Not applicable, Interventional, and Treatment
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:
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.
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.
St. Luke's Hospital, Pennsylvania is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · 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.
Other: Lalonde Protocol (standard of care)
NCLF-US therapy involves delivering low-frequency (40 kHz), low-intensity (0.1-0.8 W/cm2) ultrasound energy via sterile water mist.
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.
Wound Dimensions (mm2)
Would dimensions will be measured in two dimensions using a ruler and recorded.
Time frame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
Time to Healing (days)
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.
Time frame: From randomization through study completion (an average of 8 weeks)
Subjective Pain (Visual Analog Scale)
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.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
2 point discrimination (mm)
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.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Semmes Weinstein (Monofilament Sensitivity Test)
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.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Grip Strength (lbs)
A handgrip dynamometer will be used to determine the handgrip strength for patients in lbs. Larger numbers indicate increased strength.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Pinch Strength (lbs)
A pinch dynamometer will be used to determine the pinch strength for patients in lbs. Larger numbers indicate increased strength.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Number of Visits (n)
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.
Time frame: From randomization through study completion (an average of 8 weeks)
Functional Scores (Quick Disabilities of Arm, Shoulder, Hand)
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.
Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Plan to share: Yes — 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.
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St. Luke's Hospital, Pennsylvania