Ultrasound Therapy for Finger Amputation

Overseen By Douglas Lundy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Luke's Hospital, Pennsylvania

Disqualifiers: Vascular disease, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

22 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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.

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?

Group I: Non-Contact Low Frequency Ultrasound Experimental Treatment 2 Interventions

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.

Group II: Lalonde Protocol Active Control 1 Intervention

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Driver, VR., Yao, M., Miller, CJ.[2012]

Therapeutic ultrasound significantly enhances the healing process of full-thickness skin wounds in adult rats, as evidenced by increased granulation tissue and a favorable balance of immune cells at five days post-injury.

By day seven, while the initial benefits of ultrasound treatment were evident, the cellular differences between treated and control wounds diminished, indicating that ultrasound may primarily accelerate the early stages of wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of therapeutic ultrasound on the healing of full-thickness excised skin lesions. Young, SR., Dyson, M.[2019]

The study investigates the role of ultrasound therapy in enhancing wound healing, suggesting it may improve recovery times and tissue repair.

It also emphasizes the importance of nutrition and pressure management in the healing process, indicating that these factors are crucial for optimal recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letters. Hougton, C., Gebhardt, KS.[2019]

In a study involving 50 dogs undergoing tibial plateau leveling osteotomy, low-intensity pulsed ultrasound (LIPUS) treatment did not show any significant improvement in radiographic bone healing or limb function compared to a placebo control group over a 12-week period.

Both the LIPUS and placebo groups experienced improvements in healing and limb use, but the lack of difference between the two suggests that LIPUS may not be effective for enhancing recovery in stable osteotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low-intensity pulsed ultrasound on radiographic healing of tibial plateau leveling osteotomies in dogs: a prospective, randomized, double-blinded study. Kieves, NR., Canapp, SO., Lotsikas, PJ., et al.[2018]

Low-intensity pulsed ultrasound is clinically used to promote bone healing and soft tissue repair without causing damage to tissues, suggesting its efficacy in medical applications.

Current evidence does not support a causal link between diagnostic ultrasound exposure during pregnancy and adverse effects on the fetus, but further research is needed to explore potential developmental risks, especially given the higher output limits of modern devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal ultrasound: mechanical effects. Stratmeyer, ME., Greenleaf, JF., Dalecki, D., et al.[2019]

The VIP Ultrasound Protocol, which combines high-intensity contact ultrasound followed by low-intensity noncontact ultrasound, showed significant healing benefits for chronic wounds, with 75% of wounds in the shorter duration group (4-21 weeks) achieving over 99% improvement in wound area within 12 weeks.

Both contact and noncontact ultrasound therapies were found to be complementary, with earlier treatment initiation leading to better healing outcomes, as evidenced by a strong correlation between wound age and healing time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing Rate of Chronic and Subacute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by Noncontact Ultrasound Therapy: The VIP Ultrasound Protocol. Viana, L., Pompeo, M.[2018]

In a study involving 60 EPM-Wistar rats, 3-MHz ultrasound at both 16-Hz and 100-Hz pulse repetition frequencies significantly reduced skin flap necrosis compared to control and sham groups, indicating improved viability of the skin flaps.

Both ultrasound treatments enhanced vascular density, promoting angiogenesis, which is crucial for healing and tissue survival, with significant differences noted between the control and ultrasound-treated groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical stimulation improves survival in random-pattern skin flaps in rats. Tacani, PM., Liebano, RE., Pinfildi, CE., et al.[2010]

In a study involving 24 rats with sciatic nerve compression, early therapeutic interventions using laser and ultrasound showed significant improvements in nerve recovery compared to the control group that received no treatment.

The laser treatment (GII) was more effective than pulsed ultrasound (GIII) in promoting muscle girth recovery and overall healing, indicating that laser therapy may be a superior option for enhancing nerve regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action of therapeutic laser and ultrasound in peripheral nerve regeneration. Oliveira, FB., Pereira, VM., da Trindade, AP., et al.[2022]

In a study involving 48 rabbits, low-intensity pulsed ultrasound significantly accelerated healing at the bone-to-tendon junction, showing more newly formed bone and improved tissue integration compared to controls at 8 and 16 weeks post-surgery.

Mechanical testing revealed that the ultrasound-treated group had greater strength and load-bearing capacity, indicating that this treatment could enhance recovery and rehabilitation outcomes after tendon repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound accelerates bone-tendon junction healing: a partial patellectomy model in rabbits. Lu, H., Qin, L., Fok, P., et al.[2016]

Therapeutic ultrasound has a long history of beneficial applications in medicine, including treatments for conditions like tendinitis, kidney stones, and uterine fibroids, showcasing its efficacy across various medical fields.

While ultrasound therapy is generally safe, there are risks of undesirable side effects, such as burns and hemorrhage, highlighting the need for careful standardization and communication of safety information to optimize patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of therapeutic ultrasound applications and safety considerations. Miller, DL., Smith, NB., Bailey, MR., et al.[2022]

In a study of 29 patients with established nonunions, 86% healed after receiving daily low-intensity ultrasound treatment for an average of 22 weeks, demonstrating its efficacy in promoting bone healing.

The only significant factor affecting healing outcomes was smoking habits, suggesting that noninvasive ultrasound therapy can be a valuable option for treating nonunions, especially in non-smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound in the treatment of nonunions. Nolte, PA., van der Krans, A., Patka, P., et al.[2019]

A study involving 40 Sprague-Dawley rats found that using therapeutic ultrasound over metallic implants did not lead to increased temperature at the tissue-metal interface, suggesting safety in its application.

The ultrasound treatment did not affect callus formation or cause tissue necrosis, indicating that internal fixation with metallic implants is compatible with therapeutic ultrasound without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of therapeutic ultrasound on metallic implants: a study in rats. Kocaoğlu, B., Cabukoglu, C., Ozeras, N., et al.[2016]

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Disturbance during daily business activities (14%) and cold sensitivity (23%) were significantly lower in Group 1 compared to Group 2 (86% and ...

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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.