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

Trial Summary

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 data supports the effectiveness of the treatment Non-contact Low Frequency Ultrasound for finger amputation?

Research shows that ultrasound therapy can speed up the early stages of wound healing by promoting tissue growth and reducing inflammation. It has also been found to help in the healing of bone and soft tissue injuries in animals, suggesting it might be beneficial for similar processes in humans. ^{1 2 3 4 5}

Is ultrasound therapy generally safe for humans?

Ultrasound therapy has been used safely for many years in various medical treatments, such as physical therapy and bone healing. While there can be risks like burns or tissue damage, these are typically well-managed with proper guidelines. Low-intensity ultrasound, in particular, is considered safe and has been used to aid healing in conditions like bone fractures and chronic wounds. ^{6 7 8 9 10}

How does non-contact low-frequency ultrasound treatment for finger amputation differ from other treatments?

Non-contact low-frequency ultrasound treatment is unique because it uses sound waves to promote healing without direct contact with the wound, which can help reduce pain and infection risk. This method has been shown to significantly reduce wound size and improve healing rates in chronic wounds, making it a novel approach compared to traditional treatments that may involve direct wound contact or surgical interventions. ^{4 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of therapeutic ultrasound on the healing of full-thickness excised skin lesions. [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

Action of therapeutic laser and ultrasound in peripheral nerve regeneration. [2022]

3. United States 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound accelerates bone-tendon junction healing: a partial patellectomy model in rabbits. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Letters. [2019]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Overview of therapeutic ultrasound applications and safety considerations. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Fetal ultrasound: mechanical effects. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound in the treatment of nonunions. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The effect of therapeutic ultrasound on metallic implants: a study in rats. [2016]

11. United States 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. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Mechanical stimulation improves survival in random-pattern skin flaps in rats. [2010]

13. United States pubmed.ncbi.nlm.nih.gov

Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. [2012]