What side effects are associated with this type of intervention?

Monochromatic Infrared Photo Energy (MIRE) therapy, which improves blood flow and reduces pain, is generally well-tolerated but may cause mild skin irritation or burns if not used properly. Transcutaneous Electrical Nerve Stimulation (TENS), which stimulates nerves and reduces pain, can lead to skin irritation, muscle twitching, or discomfort at the site of electrode application. Both treatments are non-invasive and considered safe when used according to guidelines, but patients should be monitored for any adverse reactions.

What prior FDA approvals exist?

The FDA has approved various treatments for acute lower extremity swelling that align with the mechanisms of Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS). For instance, TENS devices are FDA-approved for pain relief and have been widely used to manage pain by stimulating nerves. Additionally, devices that use infrared light therapy, similar to MIRE, have been approved for improving blood circulation and reducing pain. These treatments offer non-pharmacological options for managing symptoms associated with acute lower extremity swelling.

What other types of research exist?

Promising novel alternatives for treating acute lower extremity swelling in 2024 include Low-Level Laser Therapy (LLLT), which has shown effectiveness in reducing swelling and pain, and Pneumatic Compression Therapy, which improves quality of life and reduces limb volume. Additionally, Complex Decongestive Therapy (CDT) remains a comprehensive approach combining manual lymphatic drainage, compression therapy, exercise, and skin care.

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Other

Anodyne Therapy for Lower Extremity Ischemic Pain (DTSC Trial)

N/A

Waitlist Available

Led By Doyce Cartrett, M.D.

Research Sponsored by American Association of Sensory Electrodiagnostic Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a combination of infrared light and electrical nerve stimulation can help treat lower extremity pain.

Who is the study for?

This trial is for individuals with lower extremity pain and swelling due to ischemia, who are likely to live at least 5 more years and can follow the study schedule. They must understand and sign a consent form. People may be excluded based on other factors that could affect their participation as judged by the investigator.

What is being tested?

The trial is testing how well Monochromatic Infrared Photo Energy (MIRE) combined with Transcutaneous Electrical Nerve Stimulation (TENS) therapies work in treating leg pain and swelling caused by neurological ischemia.

What are the potential side effects?

Possible side effects of MIRE and TENS treatments include skin irritation at the site of application, mild discomfort during treatment, muscle twitching, or unusual sensations like tingling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AnodyneExperimental Treatment1 Intervention

To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monochromatic Infrared Photo Energy (MIRE) improves blood flow and reduces pain by using infrared light to enhance circulation and promote tissue healing. Transcutaneous Electrical Nerve Stimulation (TENS) stimulates nerves with electrical impulses, blocking pain signals and increasing endorphin release. These treatments are important for Acute Lower Extremity Swelling patients as they address both circulatory issues and pain, offering a comprehensive approach to managing symptoms and promoting recovery.

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