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

NCT06813430 | Recruiting FDA Device

• 1 other identifier: FY2025-115
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

non-contact low frequency ultrasound; Lalonde protocol; fingertip amputation

Outcome Measures

Primary Outcomes (2)

• Wound Dimensions (mm2)

  Would dimensions will be measured in two dimensions using a ruler and recorded.

  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.

  From randomization through study completion (an average of 8 weeks)

Secondary Outcomes (7)

• Subjective Pain (Visual Analog Scale)

  Assessed weekly. From randomization through study completion (an average of 8 weeks)

• 2 point discrimination (mm)

  Assessed weekly. From randomization through study completion (an average of 8 weeks)

• Semmes Weinstein (Monofilament Sensitivity Test)

  Assessed weekly. From randomization through study completion (an average of 8 weeks)

• Grip Strength (lbs)

  Assessed weekly. From randomization through study completion (an average of 8 weeks)

• Pinch Strength (lbs)

  Assessed weekly. From randomization through study completion (an average of 8 weeks)

Study Arms (2)

Non-Contact Low Frequency Ultrasound

EXPERIMENTAL

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)

Lalonde Protocol

ACTIVE COMPARATOR

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)

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.

Non-Contact Low Frequency Ultrasound

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.

Lalonde Protocol; Non-Contact Low Frequency Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.

  PMID: 16234574 BACKGROUND

• Lee LP, Lau PY, Chan CW. A simple and efficient treatment for fingertip injuries. J Hand Surg Br. 1995 Feb;20(1):63-71. doi: 10.1016/s0266-7681(05)80019-1.

  PMID: 7759939 BACKGROUND

• Mennen U, Wiese A. Fingertip injuries management with semi-occlusive dressing. J Hand Surg Br. 1993 Aug;18(4):416-22. doi: 10.1016/0266-7681(93)90139-7.

  PMID: 8409649 BACKGROUND

• Lee DH, Mignemi ME, Crosby SN. Fingertip injuries: an update on management. J Am Acad Orthop Surg. 2013 Dec;21(12):756-66. doi: 10.5435/JAAOS-21-12-756.

  PMID: 24292932 BACKGROUND

• Peterson SL, Peterson EL, Wheatley MJ. Management of fingertip amputations. J Hand Surg Am. 2014 Oct;39(10):2093-101. doi: 10.1016/j.jhsa.2014.04.025.

  PMID: 25257490 BACKGROUND

• Sorock GS, Lombardi DA, Hauser RB, Eisen EA, Herrick RF, Mittleman MA. Acute traumatic occupational hand injuries: type, location, and severity. J Occup Environ Med. 2002 Apr;44(4):345-51. doi: 10.1097/00043764-200204000-00015.

  PMID: 11977421 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Kristofer Matullo, MD

CONTACT

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

Douglas Lundy, MD

CONTACT

douglas.lundy@sluhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: February 10, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)