Laser Therapy for Venous Leg Ulcers

Overseen By Renea D Jennings, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Immune suppressants, Steroids, Antibiotics

Disqualifiers: Pregnancy, Autoimmune disorders, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: up to 17 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immune suppressive medications or have used oral or IV antibiotics within one week before the trial.

How is laser therapy different from other treatments for venous leg ulcers?

Laser therapy for venous leg ulcers is unique because it uses low-level laser light, which may improve healing by enhancing blood flow and oxygenation in the tissues. Unlike traditional treatments, it can be combined with infrared light to potentially increase healing rates, although more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Summus Laser, Near Infrared Laser Therapy, Low-Level Laser Therapy (LLLT), Infrared Laser Irradiation for venous leg ulcers?

Research shows that combining laser therapy with infrared light may help heal venous ulcers, but more studies are needed. Low-level laser therapy (LLLT) has been used for other conditions like diabetic foot ulcers and has shown some promise in reducing pain and improving wound healing. ^{1 3 6 7 8}

Research Team

Joseph Molnar, MD

Principal Investigator

WFUHS

Eligibility Criteria

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.

Inclusion Criteria

My ulcer is between 5 and 140 cm2 in size after cleaning.

Your ankle brachial index (ABI) is higher than 0.8.

My ulcer has lasted more than 4 weeks.

Exclusion Criteria

I have not taken any antibiotics by mouth or IV in the last week.

You have an autoimmune disorder.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either therapeutic laser therapy or sham laser therapy applied to the ulcer area, with weekly evaluations and treatments

up to 17 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Summus Laser
• Summus Laser Sham

Trial Overview 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.

Participant Groups

Group I: Laser Treatment Experimental Treatment 1 Intervention

Summus Laser treatment with infrared light

Group II: Sham treatment Placebo Group 1 Intervention

Sham Summus Laser treatment with no infrared light

Summus Laser is already approved in Brazil, European Union, United States for the following indications:

Approved in Brazil as Near Infrared Laser Therapy for:

• Pain relief in chronic venous leg ulcers
• Wound healing in chronic venous leg ulcers

Approved in European Union as Low-Level Laser Therapy (LLLT) for:

• Pain relief in various conditions
• Wound healing in various conditions

Approved in United States as Infrared Laser Irradiation for:

• Temporary relief of minor muscle and joint pain
• Temporary increase in blood flow

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

A systematic review of four randomized controlled trials found no significant benefit of low-level laser therapy alone for healing venous leg ulcers compared to sham or other treatments.

However, a combination of HeNe laser and infrared light showed a significant increase in complete healing rates at nine months, suggesting that this combination may be more effective, but further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of laser therapy for venous leg ulcers. Flemming, KA., Cullum, NA., Nelson, EA.[2018]

Near-infrared low-level laser therapy (LLLT) significantly accelerates the healing of pressure ulcers in mice, achieving complete wound closure in about 18 days compared to 25 days for controls.

The effectiveness of LLLT is not dependent on temperature, as similar healing rates were observed in temperature-controlled conditions, indicating that the therapeutic benefits of LLLT are due to the light treatment itself rather than thermal effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temperature-controlled 830-nm low-level laser therapy of experimental pressure ulcers. Lanzafame, RJ., Stadler, I., Coleman, J., et al.[2015]

Low-level light therapy (LLLT) has been shown to be effective for various skin conditions and wound healing, receiving clearance in the U.S. for cosmetic improvements and pain reduction, indicating its broad therapeutic potential.

Despite its widespread use, there is a lack of well-designed clinical trials that systematically evaluate the optimal parameters (like wavelength and energy dose) for LLLT, which can lead to confusion in its application for different types of wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound Phototherapy. Bolton, LL.[2021]

Low-level light therapy (LLLT) has been shown to effectively reduce the area of diabetic foot ulcers (DFUs) and improve the complete healing rate, based on a systematic review of seven randomized control trials involving 194 participants.

LLLT is a noninvasive treatment option that promotes rapid healing and alleviates pain associated with DFUs, with no reported adverse events, suggesting it is a safe therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low-level light therapy for treatment of diabetic foot ulcer: A systematic review and meta-analysis of randomized controlled trials. Li, S., Wang, C., Wang, B., et al.[2019]

In a study of 24 patients with chronic venous leg ulcers, low-level laser therapy (LLLT) did not show a statistically significant advantage over placebo in achieving complete wound closure or reducing ulcer size after 12 weeks.

However, LLLT was associated with a significant reduction in pain scores, suggesting it may have delayed effects on pain relief in patients with venous leg ulcers, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of Low-Level Laser Therapy on Venous Leg Ulcers. Vitse, J., Bekara, F., Byun, S., et al.[2022]

Low-intensity helium-neon laser therapy has been shown to provide significant pain relief and improve healing in patients with acute thrombophlebitis of the lower limbs.

This laser treatment enhances microcirculation and oxygenation in tissues, leading to faster wound healing and making it a preferred option for treating trophic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of acute thrombophlebitis of the lower limbs with laser irradiation]. Dudenko, GI., Zaliubovskiĭ, VI.[2007]

A new combined laser therapy (LT) method using the LASMIK® device significantly reduces the time needed for wound cleansing and promotes healing processes in patients with trophic ulcers of venous etiology, showing 2-2.7 times faster results compared to traditional treatments.

The study highlights the effectiveness of combining laser therapy with conventional treatment methods, suggesting that this approach can enhance the overall management of chronic venous diseases classified as C6.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of a New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency. Moskvin, SV., Geynitz, AV., Askhadulin, EV.[2020]

A systematic review of 4 randomized controlled trials found no significant benefit of low level laser therapy compared to sham treatments or other light therapies for healing venous leg ulcers.

One small study indicated that combining laser therapy with infrared light may improve healing rates compared to non-coherent red light, but further research is necessary to confirm this finding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser therapy for venous leg ulcers. Flemming, K., Cullum, N.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of laser therapy for venous leg ulcers. [2018]

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

Temperature-controlled 830-nm low-level laser therapy of experimental pressure ulcers. [2015]

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

Wound Phototherapy. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of low-level light therapy for treatment of diabetic foot ulcer: A systematic review and meta-analysis of randomized controlled trials. [2019]

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

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of Low-Level Laser Therapy on Venous Leg Ulcers. [2022]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Treatment of acute thrombophlebitis of the lower limbs with laser irradiation]. [2007]

7. Iran pubmed.ncbi.nlm.nih.gov

Efficiency of a New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency. [2020]

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

Laser therapy for venous leg ulcers. [2018]