Clinical trial NCT06813430: Non-Contact Low-Frequency Ultrasound Vs Standard LaLonde Protocol for Fingertip Injury Wound Healing
Official title: Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-contact Low Frequency Ultrasound
Lalonde Protocol
Fingertip Amputation
Keywords: non-contact low frequency ultrasound
Lalonde protocol
fingertip amputation
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound Dimensions (mm2)
timeFrame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
measure: Time to Healing (days)
timeFrame: From randomization through study completion (an average of 8 weeks)
Secondary outcomes:
measure: Subjective Pain (Visual Analog Scale)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
measure: 2 point discrimination (mm)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
measure: Semmes Weinstein (Monofilament Sensitivity Test)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
measure: Grip Strength (lbs)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
measure: Pinch Strength (lbs)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
measure: Number of Visits (n)
timeFrame: From randomization through study completion (an average of 8 weeks)
measure: Functional Scores (Quick Disabilities of Arm, Shoulder, Hand)
timeFrame: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
Study officials:
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