25 Participants Needed

Photoacoustic Imaging for Foot Ulcer

JX
Overseen ByJun Xia, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
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 imaging technique called photoacoustic imaging, which may help doctors better monitor and treat foot ulcers. Foot ulcers are open sores that often heal slowly due to poor blood flow. The trial aims to determine if this imaging can effectively guide treatment after surgery. Individuals with a chronic foot ulcer caused by poor blood circulation might be suitable candidates for the trial.

As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance future treatment options for foot ulcers.

Will I have to stop taking my current medications?

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 device is safe for monitoring foot ulcers?

Research has shown that photoacoustic imaging, a technique using sound and light to visualize the body, holds promise for safely assessing and treating foot ulcers. Studies have found that this method can monitor wound healing and detect problems early. Importantly, research in both humans and animals has not reported any serious side effects, suggesting that photoacoustic imaging is generally safe and well-tolerated. However, ongoing studies aim to further confirm its safety and effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about photoacoustic imaging for foot ulcers because it offers a non-invasive way to visualize the underlying condition of the ulcerated tissue. Traditional methods, like physical examination and sometimes invasive biopsies, can be less precise and more uncomfortable for patients. Photoacoustic imaging combines light and sound to create detailed images of the tissues, providing clearer insights into blood vessel health and tissue oxygenation. This potentially allows for earlier and more accurate assessment of foot ulcers, which is crucial for effective treatment and prevention of complications.

What evidence suggests that photoacoustic imaging is effective for monitoring foot ulcers?

Research shows that photoacoustic imaging, which participants in this trial will undergo, can help monitor diabetic foot ulcers. Studies have found it to be a reliable way to check blood flow in the small blood vessels of the foot. Good blood flow is important because it can speed up healing. Photoacoustic imaging gives doctors a clearer view of how well a foot ulcer is healing by examining blood flow. This method may assist doctors in making better treatment decisions for foot ulcers. Although this research is still in the early stages, it holds promise for improving wound care.23678

Are You a Good Fit for This Trial?

This trial is for patients with chronic foot wounds presumed from poor blood flow. It's not for those who don't follow care plans, pregnant women, people with deep infections or certain skin conditions near the wound, or adults unable to consent.

Inclusion Criteria

I have a long-lasting wound on my foot caused by poor blood flow.

Exclusion Criteria

Noncompliant patients who do not adhere to care plans
Pregnant women
I have a severe infection in my deep tissues.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo imaging using the investigational photoacoustic device to guide post-surgical wound treatment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Photoacoustic Imaging
Trial Overview The study tests photoacoustic imaging to monitor blood supply in foot wounds and guide treatment after surgery. It's a pilot trial to check how well this works and gather data for planning bigger future studies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single study armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Citations

Diabetic Foot Ulcer Imaging: An Overview and Future ...Diabetic foot ulcers (DFUs) affect one in every three people with diabetes. Imaging plays a vital role in objectively complementing the gold-standard visual yet ...
Photoacoustic imaging: a unique imaging examination for ...This article reviews the current animal experiments and human studies on microvascular lesions, peripheral vascular lesions, diabetic foot, and ...
Radiomics-Driven Perfusion Prediction in Clinical ...This study demonstrates a reliable and interpretable method for perfusion assessment in PA imaging with strong clinical potential. Keywords.
A few-shot diabetes foot ulcer image classification method ...The objective of the study is to propose a few-shot DFU image classification method based on deep residual neural network and transfer learning.
Photoacoustic imaging to monitor outcomes during ...(10) A study in 2013 evaluating 602 diabetic patients with ischemic foot ulcers treated without revascularization showed that only 50% and 17% ...
The Potential of Photoacoustic Imaging in Detecting and ...PAI systems have shown substantial clinical value in real-time monitoring and early diagnosis of diabetic foot ulcers, burn wounds, and both ...
Diabetic Foot Ulcer Imaging: An Overview and Future ...This manuscript aims to present a comprehensive overview, rather than a systematic review, of various imaging modalities employed in the management of diabetic ...
Use of thermal imaging in the detection of the diabetic footFindings show that thermal imaging can detect abnormal skin temperature patterns and early inflammation, key indicators of DFU development. AI ...
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