What side effects are associated with this type of intervention?

Common treatments for venous leg ulcers, such as laser therapy using infrared light, can have side effects including skin irritation, redness, and temporary pain at the treatment site. There is also a risk of burns if the laser settings are not properly managed. Other treatments like compression therapy may cause discomfort, skin irritation, or allergic reactions to the materials used. Invasive procedures, such as vein ablation, carry risks of infection, bleeding, and deep vein thrombosis. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved various treatments for venous leg ulcers, including compression therapy, wound dressings, and medications to improve blood flow. While specific FDA approvals for infrared laser therapy for venous leg ulcers are not detailed, similar treatments like low-level laser therapy (LLLT) and other light-based therapies have been explored for their potential to enhance wound healing and increase blood circulation. These therapies aim to reduce pain and promote tissue repair through mechanisms such as photobiomodulation.

What other types of research exist?

Promising novel alternatives to laser therapy for venous leg ulcer patients include: <ol> <li>Pneumatic Compression Therapy: This has been shown to improve quality of life and is effective in long-term management of lymphedema, which can be associated with venous ulcers.</li> <li>Complete Decongestive Physical Therapy (CDPT): Effective in managing secondary lymphedema, which can aid in reducing venous ulcer complications.</li> <li>Advanced Pneumatic Compression Devices: These devices offer clinical and health economic benefits, improving outcomes for patients with lymphedema and potentially venous ulcers.</li> <li>Photodynamic Therapy (PDT): Although primarily used for actinic keratosis, PDT has shown potential in improving wound healing and reducing pain in various dermatological conditions.</li> </ol>

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Near Infrared Laser Therapy

Laser Therapy for Venous Leg Ulcers

N/A

Recruiting

Led By Joseph Molnar, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Ulcer duration longer than 4 weeks

Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis

Must not have

Immune suppressive meds, Including steroids

Pregnant, nursing or child bearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 17 weeks

Summary

This trial uses the Summus Laser Cube, a device that shines infrared light to warm up the skin and tissues. It aims to help patients with venous leg ulcers by reducing pain and stiffness and improving blood flow. Low-level laser therapy has been suggested to have a biostimulative and wound healing effect, but its efficacy in treating venous leg ulcers has not been conclusively verified.

Who is the study for?

This trial is for adults over 18 with chronic venous leg ulcers larger than 5 cm2 but smaller than 140 cm2, experiencing pain and having an ABI above 0.8. It's not for pregnant women, those who've had recent venous treatments or use immune-suppressing drugs, have certain comorbidities like uncontrolled diabetes, a BMI outside of the range of 15-50, or tattoos near the ulcer.

What is being tested?

The study tests if Near Infrared Laser Therapy can relieve pain and speed up healing in venous leg ulcers. Participants will be randomly assigned to receive either real Summus Laser treatment or a sham (placebo) version to compare outcomes.

What are the potential side effects?

Potential side effects may include temporary discomfort at the site of application, skin irritation from heat exposure during laser therapy sessions, and possible changes in skin pigmentation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ulcer has lasted more than 4 weeks.

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I have been diagnosed with venous insufficiency.

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I am 18 years old or older.

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I have an ulcer on my lower limb in an area affected by poor blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking immune-suppressing medications, including steroids.

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I am currently pregnant, nursing, or able to bear children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain measured by survey

Secondary study objectives

Infectious complications

Quality of Life Questionnaire

Venous Ulcer rate of healing

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Laser TreatmentExperimental Treatment1 Intervention

Summus Laser treatment with infrared light

Group II: Sham treatmentPlacebo Group1 Intervention

Sham Summus Laser treatment with no infrared light

0 / 6Eligibility criteria met

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

Common treatments for Venous Leg Ulcers (VLUs) include laser therapy, compression therapy, and various forms of wound care. Laser therapy, particularly using infrared light, works by heating the skin and underlying tissues, which temporarily relieves pain and stiffness and increases blood flow. This enhanced blood flow can promote healing by delivering more oxygen and nutrients to the affected area. Compression therapy improves venous return, reduces edema, and prevents blood from pooling in the legs, which is crucial for healing and preventing ulcer recurrence. Effective wound care, including debridement and the use of appropriate dressings, helps to maintain a moist environment conducive to healing and prevents infection. These treatments are vital for VLU patients as they address both the symptoms and underlying causes of ulcers, thereby improving healing rates and quality of life.