Non-contact Low Frequency UltrasoundNCT06813430
Non-Contact Low-Frequency Ultrasound Vs Standard LaLonde Protocol for Fingertip Injury Wound Healing
A study testing Non-contact Low Frequency Ultrasound in people with Non-contact Low Frequency Ultrasound and Lalonde Protocol, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-contact Low Frequency Ultrasound, Lalonde Protocol, Fingertip Amputation
- What is being tested?
- Non-contact Low Frequency Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Douglas Lundy, MD contact
United States1 site, 1 recruiting
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Kristofer Matullo, MD, 484-526-1735, Kristofer.Matullo@sluhn.org
Kristofer Matullo, MD
About this study
Official title: Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
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.
Read the 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.
- Being tested
- Non-contact Low Frequency Ultrasound, Lalonde Protocol (standard of care)
- Keywords
- non-contact low frequency ultrasound, Lalonde protocol, fingertip amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact Low Frequency UltrasoundDevice
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Lalonde Protocol (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Dimensions (mm2)
Would dimensions will be measured in two dimensions using a ruler and recorded.
Measured: 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.
Measured: From randomization through study completion (an average of 8 weeks)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed weekly. From randomization through study completion (an average of 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start10 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Non-contact Low Frequency UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813430
- Sponsor's protocol ID
- FY2025-115
- Status last verified
- May 2025
- First submitted
- 31 Jan 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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.
PubMed 23163982Kavros 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.
PubMed 17369314Kavros 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.
PubMed 17415030Driver 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.
PubMed 21649783Escandon 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.
PubMed 22296347Olyaie 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.
PubMed 23934374Kavros 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.
PubMed 18769168Ennis 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.
PubMed 17008814Ennis 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.
PubMed 16234574Lee 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.
PubMed 7759939Mennen 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.
PubMed 8409649Lee 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.
PubMed 24292932Peterson 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.
PubMed 25257490Sorock 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.
PubMed 11977421
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT06813430
- Acronym / sponsor ID
- FY2025-115
- Keywords
- non-contact low frequency ultrasound, Lalonde protocol, fingertip amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Contact Low Frequency Ultrasound | Experimental | Device: Non-contact Low Frequency Ultrasound, Other: Lalonde Protocol (standard of care)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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contact Low Frequency UltrasoundNCLF-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 |
| 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, Non-Contact Low Frequency Ultrasound |
Primary outcome
Wound Dimensions (mm2)
Time frame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
Would dimensions will be measured in two dimensions using a ruler and recorded.
Time to Healing (days)
Time frame: From randomization through study completion (an average of 8 weeks)
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.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 23163982Yao 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.
- Background: PubMed 17369314Kavros 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.
- Background: PubMed 17415030Kavros 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.
- Background: PubMed 21649783Driver 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.
- Background: PubMed 22296347Escandon 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.
- Background: PubMed 23934374Olyaie 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.
- Background: PubMed 18769168Kavros 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.
- Background: PubMed 17008814Ennis 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.
- Background: PubMed 16234574Ennis 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.
- Background: PubMed 7759939Lee 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.
- Background: PubMed 8409649Mennen 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.
- Background: PubMed 24292932Lee 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas Lundy, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contact Low Frequency Ultrasound in people with Non-contact Low Frequency Ultrasound and Lalonde Protocol, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristofer Matullo, MD (484-526-1735, Kristofer.Matullo@sluhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Dimensions (mm2) (time frame: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813430, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.