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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed weekly. From randomization through study completion (an average of 8 weeks) |
| 2 point discrimination (mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristofer Matullo, MD | Contact | 484-526-1735 | Kristofer.Matullo@sluhn.org | |
| Douglas Lundy, MD | Contact | douglas.lundy@sluhn.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23163982 | Background | 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. | |
| 17369314 | Background |
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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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| 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Assessed weekly. From randomization through study completion (an average of 8 weeks) |
| 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. |
| 17415030 | 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. |
| 21649783 | 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. |
| 22296347 | 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. |
| 23934374 | 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. |
| 18769168 | 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. |
| 17008814 | 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. |
| 16234574 | 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. |
| 7759939 | 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. |
| 8409649 | 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. |
| 24292932 | 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. |
| 25257490 | 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. |
| 11977421 | 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. |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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