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

Overview

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.

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.

Primary outcome measures

• 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)]

Secondary outcome measures (7)

• Subjective Pain (Visual Analog Scale) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]
• 2 point discrimination (mm) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]
• Semmes Weinstein (Monofilament Sensitivity Test) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]
• Grip Strength (lbs) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]
• Pinch Strength (lbs) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]
• Number of Visits (n) [Time frame: From randomization through study completion (an average of 8 weeks)]
• Functional Scores (Quick Disabilities of Arm, Shoulder, Hand) [Time frame: Assessed weekly. From randomization through study completion (an average of 8 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• St. Luke's University Health Network — Bethlehem

Publications

• Yao M, Hasturk H, Kantarci A, Gu G, Garcia-Lavin S, Fabbi M, Park N, Hayashi H, Attala K, French MA, Driver VR. A pilot study evaluating non-contact low-frequency ultrasound and underlying molecular mechanism on diabetic foot ulcers. Int Wound J. 2014 Dec;11(6):586-93. doi: 10.1111/iwj.12005. Epub 2012 Nov 19. PMID 23163982
• Kavros SJ, Schenck EC. Use of noncontact low-frequency ultrasound in the treatment of chronic foot and leg ulcerations: a 51-patient analysis. J Am Podiatr Med Assoc. 2007 Mar-Apr;97(2):95-101. doi: 10.7547/0970095. PMID 17369314
• Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006. Adv Skin Wound Care. 2007 Apr;20(4):221-6. doi: 10.1097/01.ASW.0000266660.88900.38. PMID 17415030
• Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair Regen. 2011 Jul-Aug;19(4):475-80. doi: 10.1111/j.1524-475X.2011.00701.x. Epub 2011 Jun 7. PMID 21649783
• Escandon J, Vivas AC, Perez R, Kirsner R, Davis S. A prospective pilot study of ultrasound therapy effectiveness in refractory venous leg ulcers. Int Wound J. 2012 Oct;9(5):570-8. doi: 10.1111/j.1742-481X.2011.00921.x. Epub 2012 Feb 1. PMID 22296347
• Olyaie M, Rad FS, Elahifar MA, Garkaz A, Mahsa G. High-frequency and noncontact low-frequency ultrasound therapy for venous leg ulcer treatment: a randomized, controlled study. Ostomy Wound Manage. 2013 Aug;59(8):14-20. PMID 23934374
• Kavros SJ, Liedl DA, Boon AJ, Miller JL, Hobbs JA, Andrews KL. Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. Adv Skin Wound Care. 2008 Sep;21(9):416-23. doi: 10.1097/01.ASW.0000323546.04734.31. PMID 18769168
• Ennis WJ, Valdes W, Gainer M, Meneses P. Evaluation of clinical effectiveness of MIST ultrasound therapy for the healing of chronic wounds. Adv Skin Wound Care. 2006 Oct;19(8):437-46. doi: 10.1097/00129334-200610000-00011. PMID 17008814

Identifiers

NCT: NCT06813430 · FY2025-115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗