22 Participants Needed

Ultrasound Therapy for Finger Amputation

KM
DL
Overseen ByDouglas Lundy, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: St. Luke's Hospital, Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to heal fingertip amputations using non-contact low-frequency ultrasound therapy. Researchers aim to determine if this method improves recovery compared to the standard treatment of cleaning and bandaging the wound. Participants will be randomly assigned to receive either ultrasound therapy or the standard treatment, with therapy sessions occurring a few times a week. The trial seeks individuals who have recently experienced a fingertip amputation without exposed bone or tendons. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance healing methods for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that non-contact low frequency ultrasound is safe for treating fingertip amputations?

Earlier studies have shown promising results with non-contact low frequency ultrasound. Participants reported fewer issues, such as disruptions in daily activities and sensitivity to cold, compared to those using other methods. However, limited information exists about potential side effects or negative reactions, so further research is needed to understand its safety in humans. The treatment applies a gentle ultrasound mist to the wound, a method safely used in other wound care types. Since this study does not focus on in-depth safety testing, monitoring for new information or findings is important.12345

Why are researchers excited about this trial?

Unlike the standard of care for finger amputation, which usually involves basic wound management techniques like rinsing and wrapping, the non-contact low-frequency ultrasound (NCLF-US) therapy introduces a new approach using ultrasound energy delivered through a sterile water mist. This method is unique because it potentially enhances healing by stimulating tissue repair and reducing inflammation without direct contact with the wound. Researchers are excited about this treatment because it could speed up recovery and improve healing outcomes compared to traditional methods.

What evidence suggests that non-contact low frequency ultrasound is effective for fingertip amputations?

This trial will compare non-contact low-frequency ultrasound therapy with the Lalonde protocol for treating fingertip amputations. Studies have shown that non-contact low-frequency ultrasound can speed up healing in fingertip amputations compared to traditional methods. Specifically, one study found that a treatment called UltraMIST helped fingertip injuries heal nine times faster than the usual Lalonde method. This ultrasound therapy uses sound waves and a mist to aid healing without touching the wound. It likely works by improving blood flow and reducing swelling and irritation. These early findings suggest that non-contact low-frequency ultrasound could be a promising new option for people with fingertip amputations.16789

Are You a Good Fit for This Trial?

This trial is for individuals who have recently experienced a fingertip amputation. Participants will be chosen randomly to receive either the standard Lalonde protocol or non-contact low-frequency ultrasound treatments 2-3 times weekly, with wound measurements taken once a week.

Inclusion Criteria

I am 18 or older and have a fingertip cut off without showing bone or tendon.

Exclusion Criteria

Injuries involving exposed bone
I am suspected of or have been diagnosed with an infection.
I have been diagnosed with a vascular disease.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either non-contact low-frequency ultrasound therapy or standard Lalonde protocol therapy for fingertip amputations

8 weeks
2-3 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-contact Low Frequency Ultrasound
Trial Overview The study aims to determine if non-contact low-frequency ultrasound can improve healing outcomes compared to the standard Lalonde protocol in patients with acute fingertip amputations. The effectiveness of each treatment will be evaluated based on wound care therapy results.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Contact Low Frequency UltrasoundExperimental Treatment2 Interventions
Group II: Lalonde ProtocolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Luke's Hospital, Pennsylvania

Lead Sponsor

Trials
21
Recruited
3,400+

Published Research Related to This Trial

In a study of 210 patients, those receiving MIST Therapy in addition to standard wound care had a significantly higher healing rate (53%) compared to those receiving only standard care (32%).
MIST Therapy also resulted in a faster healing rate, with a steeper regression slope (1.4) compared to the control group (0.22), indicating that this therapy enhances the effectiveness of standard wound care for chronic lower-extremity wounds.
Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis.Kavros, SJ., Liedl, DA., Boon, AJ., et al.[2008]
Low-frequency ultrasound (20-30 kHz) used as an adjunctive therapy significantly improves early healing outcomes in chronic lower limb wounds, particularly in patients with venous stasis and diabetic foot ulcers, as shown in a systematic review of 8 randomized controlled trials.
Both high-intensity contact and low-intensity noncontact ultrasound techniques were effective in promoting healing within 5 months, although the quality of evidence for low-intensity noncontact ultrasound was questioned due to potential biases.
Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials.Voigt, J., Wendelken, M., Driver, V., et al.[2018]
Noncontact low-frequency ultrasound (NLFU) therapy significantly reduced chronic wound area by an average of 85.2% over approximately 7 weeks, based on data from 188 patients.
NLFU also led to a substantial reduction in wound volume by 79.7% over about 12 weeks, with healing rates showing that 32.7% of wounds healed by 6 weeks and 41.7% by 12 weeks, indicating its efficacy in promoting wound healing.
Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis.Driver, VR., Yao, M., Miller, CJ.[2012]

Citations

Enhancing Healing with Noncontact Low-Frequency ...This study aimed to evaluate the efficacy of noncontact low-frequency ultrasound (NCLF-US) as adjunctive therapy for treatment of fingertip amputations. Methods.
Enhancing Fingertip Amputation Healing: UltraMIST Versus ...Conclusion UltraMIST treatment decreased the time to healing of traumatic fingertip amputations nine times faster than LaLonde protocol, even ...
Non-Contact Low-Frequency Ultrasound Vs Standard ...This study aimed to compare the efficacy of NCLF-US in combination with standard treatment for secondary healing versus the standard treatment ...
Ultrasound Therapy for Finger AmputationThe goal of this clinical trial is to compare the efficacy of non-contact low frequency ultrasound in populations sustaining fingertip amputations. The main ...
(PDF) Enhancing Healing with Noncontact Low-Frequency ...Acute traumatic fingertip amputations are common injuries. This study aimed to evaluate the efficacy of noncontact low-frequency ultrasound ...
Enhancing Fingertip Amputation Healing: UltraMIST ...Disturbance during daily business activities (14%) and cold sensitivity (23%) were significantly lower in Group 1 compared to Group 2 (86% and ...
Non-Contact Low-Frequency Ultrasound Vs Standard ...Does non-contact low frequency ultrasound significantly improve patient outcomes in patients sustaining acute fingertip amputations?
Noncontact Warming Therapy, Ultrasound ...The outcomes of adverse effects, quality of life and cost were not reported for low-frequency ultrasound treatment. The authors concluded that ...
Comparisons of negative pressure wound therapy and ...Negative-pressure wound therapy appears to be as effective as ultrasound debridement for diabetic foot ulcers compared with standard wound therapy.
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