Microvessel Ultrasound Imaging for Chronic Ulcers

Overseen By Michael R Moynagh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antibiotics

Disqualifiers: Smoking, Pregnancy, Poor blood supply, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using ultrasound imaging to track and improve healing in chronic ulcers, specifically diabetic foot ulcers and venous ulcers. Researchers aim to determine if this imaging can detect scarring and enhance blood flow around the wound. Participants will undergo a special ultrasound exam (Microvessel Ultrasound Examination) and provide two small skin samples (Skin Biopsy). Suitable candidates have had a diabetic or venous ulcer for at least 6 weeks, with minimal reduction despite standard care.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance ulcer treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this microvessel ultrasound imaging is safe for monitoring chronic ulcers?

Research has shown that microvessel ultrasound imaging is generally safe. It allows doctors to view tiny blood vessels in chronic ulcers without cutting the skin. No clear reports of harmful effects from this type of ultrasound exist.

Other studies have used ultrasound to aid in healing leg ulcers. Although these studies did not specifically focus on the safety of microvessel ultrasound, they also did not report any serious side effects.

Overall, microvessel ultrasound imaging appears well-tolerated. As a non-invasive method, it does not require surgery or breaking the skin, making it a safer option for checking and monitoring wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic ulcers, like diabetic and venous ulcers, involve wound care techniques such as debridement and dressings to promote healing. However, researchers are excited about using microvessel ultrasound imaging because it offers a unique way to visualize blood flow in the small vessels around the wound. This technique helps in understanding how blood supply affects healing, something current treatments don't address. By gaining insights into microvascular health, this approach could lead to more targeted and effective treatments in the future.

What evidence suggests that microvessel ultrasound imaging is effective for chronic ulcers?

Research shows that microvessel ultrasound imaging can help monitor chronic ulcers. Studies have found that this technique tracks blood flow and tiny blood vessels around wounds effectively. In this trial, participants with chronic diabetic ulcers and venous ulcers will receive microvessel ultrasound examinations alongside standard wound care. While not a treatment on its own, it helps doctors assess wound healing. In some cases, ultrasound has shown promise in aiding the healing of venous ulcers, which result from poor blood flow. Although not a direct cure, this imaging might enhance wound care by providing detailed information on blood circulation. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Moynagh, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with chronic ulcers on their lower extremities that have not healed in at least 6 weeks and are between 2-15 sq. cm in size. Participants must have controlled blood sugar, adequate blood flow to the wound, and no active infections or allergies to lidocaine. Smokers and pregnant individuals cannot participate.

Inclusion Criteria

Ankle-brachial index (ABI) ≥ 0.8

I have a long-lasting wound from diabetes or poor leg circulation that's between 2 and 15 sq. cm large, without any signs of infection.

For chronic venous ulcers, ultrasound demonstrates venous reflux >0.5 seconds

Exclusion Criteria

You are allergic to lidocaine.

For chronic venous ulcers, ultrasound demonstrates venous reflux <0.5 seconds

My diabetic foot wound has a poor blood supply, confirmed by a TCPO2 test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microvessel Ultrasound Examination
• Skin Biopsy

Trial Overview The study tests a high-resolution microvessel ultrasound imaging system's ability to detect scarring and monitor healing in chronic wounds. It also examines how treatments affect tiny blood vessels and circulation around the wound.

How Is the Trial Designed?

Group I: Microvessel Ultrasound Imaging for Chronic Ulcers Experimental Treatment 2 Interventions

Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 20 patients with chronic leg ulcers, those treated with Apligraf showed clinical healing within 5 weeks, while conventional management took several months for some cases.

High-resolution ultrasound (HR-US) revealed significant underlying structural deficits in the skin, even when ulcers appeared clinically healed, indicating that visual inspection alone may not fully assess the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of high-resolution ultrasound to monitor the healing of leg ulcers: a prospective single-center study. Kuhn, C., Angehrn, F.[2022]

In a study involving 96 male hamsters, the use of ultrasound, both alone and with microbubbles, was found to reduce inflammation by decreasing the number of rolling and adhered leukocytes in conditions like ischemia-reperfusion and hyperinsulinemia.

The ultrasound treatment also increased venular diameter in the ischemia-reperfusion group, suggesting a potential therapeutic benefit in improving microcirculation without increasing leukocyte adhesion, which is important for safety in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of microbubbles and ultrasound on the microcirculation: observation on the hamster cheek pouch. Camarozano, AC., Garcia de Almeida Cyrino, FZ., Bottino, DA., et al.[2022]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

The study introduces a faster version of raster-scan optoacoustic mesoscopy (Fast RSOM) that allows for high-resolution imaging of melanoma vasculature in just 15 seconds, significantly reducing motion artifacts caused by breathing.

Fast RSOM was applied to image 10 melanoma lesions and 10 benign nevi, revealing distinct vascular differences between malignant and benign lesions, suggesting its potential as a diagnostic tool for better lesion characterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast raster-scan optoacoustic mesoscopy enables assessment of human melanoma microvasculature in vivo. He, H., Schönmann, C., Schwarz, M., et al.[2022]

High-frequency ultrasound imaging is a promising and safe method for assessing neonatal skin, as demonstrated in a study of 72 newborns, where it effectively measured skin structure without any lesions.

The study found that newborns with higher birth weights had thicker epidermis, indicating that ultrasound can reveal important skin characteristics, although sex and blood gas pH levels did not significantly affect skin features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound image of healthy skin in newborns in the first 24 hours of life. Przybysz, P., Jackowska, T., Wilińska, M., et al.[2022]

Microfocused ultrasound with visualization (MFU-V) is well tolerated and does not negatively affect skin barrier function or physiology, as shown in a study of 22 female patients over 24 weeks.

Significant improvements in skin elasticity were observed at 12 and 24 weeks post-treatment, indicating effective dermal tissue remodeling, which aligns with the expected mechanism of action of MFU-V.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity. Kerscher, M., Nurrisyanti, AT., Eiben-Nielson, C., et al.[2022]

In a study of 16 patients with diabetic foot ulcers, contrast-enhanced ultrasound provided detailed imaging features, showing slow enhancement in the artery phase and revealing a greater ulcerous area compared to conventional ultrasound.

The technique demonstrated different enhancement patterns, which can help in evaluating the severity of ulcers and monitoring treatment efficacy, making it a valuable tool in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast-enhanced ultrasound imaging features of diabetic foot ulcers]. Zhang, X., Liu, HW., Lv, YC., et al.[2016]

This study is the first to investigate the use of ultrasound elastography to measure changes in tissue stiffness related to pressure ulcer development in humans, involving nine healthy volunteers who underwent prolonged loading on specific body areas.

Results showed that continuous pressure increases skin and subcutaneous tissue stiffness, with different responses observed in superficial and deeper tissues, suggesting that shear wave velocity could be a valuable new measure for assessing the risk of pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using ultrasound elastography to monitor human soft tissue behaviour during prolonged loading: A clinical explorative study. Schäfer, G., Dobos, G., Lünnemann, L., et al.[2016]

In a study involving 50 vascular surgery inpatients, high-frequency ultrasound imaging was used to assess subcutaneous tissue damage, revealing discrepancies between ultrasound findings and clinical skin assessments, particularly in heel evaluations.

While ultrasound images suggested more severe tissue damage (grade 2 pressure ulceration) than clinical assessments indicated (grade 1a), the technique shows promise as a supplementary tool for identifying underlying tissue issues, warranting further research for better correlation with pressure ulcer staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do high frequency ultrasound images support clinical skin assessment? Porter-Armstrong, AP., Adams, C., Moorhead, AS., et al.[2021]

Podiatrists with musculoskeletal ultrasound training can effectively use ultrasound imaging to assess diabetic foot ulcers (DFUs), demonstrating the potential for improved clinical evaluations beyond traditional visual methods.

The study revealed that while podiatrists consistently identified key characteristics of DFUs, there was variability in reporting soft-tissue observations, indicating a need for standardized protocols and training to enhance the reliability of ultrasound assessments in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of podiatrists, with knowledge and training in diagnostic musculoskeletal ultrasound, to describe sonographic images of diabetic foot wounds in the United Kingdom and Australia. Dando, C., Lane, G., Bowen, C., et al.[2023]

The study used skin ultrasound to assess nail texture in adults with mild irritant hand eczema (IHE) and found significant differences in nail characteristics compared to those without IHE, indicating that ultrasound is effective for evaluating nail health.

Nails affected by IHE were observed to be thicker and more uneven, suggesting that mild irritation can lead to noticeable changes in nail morphology, although the density of the nails remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of nail heath conditions with skin ultrasound. Ruan, J., Wang, XM., Xia, MN.[2016]

High-resolution ultrasound can effectively detect early changes in skin and soft tissue associated with pressure ulcer development in at-risk individuals, revealing abnormalities in 55.3% of images from long-term-care residents compared to healthy volunteers.

The study suggests that pressure ulcer development follows a progressive pattern from deep subdermal layers to superficial layers, with dermal edema only occurring in the presence of subdermal edema, highlighting the potential for ultrasound to identify issues before visible signs appear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of high-resolution, high-frequency diagnostic ultrasound to investigate the pathogenesis of pressure ulcer development. Quintavalle, PR., Lyder, CH., Mertz, PJ., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05739149

A Study to Evaluate Microvessel Ultrasound Imaging of ... For chronic venous ulcers, ultrasound demonstrates venous reflux <0.5 seconds; Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c <6.5% ...

2. withpower.com withpower.com/trial/microvessel-ultrasound-imaging-for-chronic-ulcers-2b9ae

Microvessel Ultrasound Imaging for Chronic Ulcers In a study of 20 patients with chronic leg ulcers, those treated with Apligraf showed clinical healing within 5 weeks, while conventional management took ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20547548

A Study to Evaluate Microvessel Ultrasound Imaging of ... The purpose of this study is to explore the application of high-resolution microvessel ultrasound imaging system to non-invasively monitor the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481488/

Therapeutic ultrasound for venous leg ulcers - PMC While compression therapy (such as bandages or stockings) is an effective first‐line treatment, ultrasound may have a role to play in healing venous ulcers.

5. sciencedirect.com sciencedirect.com/science/article/pii/S305065812500189X

Diagnostic assessment for venous leg ulcers: ... Venous leg ulcers (VLU) impair patients' quality of life and result in significant costs for society and is the consequence of chronic venous disease.

6. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1580568/full

A case series of using ultrasound-guided continuous ... Results: Among the nine patients, six achieved complete healing of their diabetic foot ulcers, while the remaining three showed significant ...