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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if laser therapy (Summus Laser) can heal venous leg ulcers, painful wounds on the lower leg caused by poor blood flow. The treatment uses infrared light to heat the skin, potentially easing pain and boosting blood circulation. Participants will receive either the actual laser treatment or a placebo to compare results. Individuals who have had a venous leg ulcer for more than four weeks and experience pain might be suitable candidates for the study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for venous leg ulcers.

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.

What prior data suggests that this laser therapy is safe for treating venous leg ulcers?

Research shows that the Summus Laser is generally safe and well-tolerated. This laser therapy uses infrared light to gently warm the skin and tissues, aiming to temporarily relieve minor pain and stiffness associated with arthritis. Studies have not identified any major safety concerns, and the treatment is non-invasive, meaning it doesn't involve surgery or breaking the skin.

Previous studies on similar laser therapies for other conditions have not reported significant negative side effects. However, like any treatment, minor side effects such as temporary redness or warmth at the application site can occur. The Summus Laser is already used for other health conditions, suggesting it is reasonably safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for venous leg ulcers, which often involve compression therapy and specialized dressings, Summus Laser therapy is unique because it uses infrared light to promote healing. This non-invasive approach targets the affected area directly, potentially accelerating the healing process without the discomfort associated with traditional methods. Researchers are excited about its ability to stimulate tissue repair and improve blood circulation, offering a promising alternative for patients who have not responded well to conventional treatments.

What evidence suggests that laser therapy is effective for venous leg ulcers?

Research has shown that near-infrared low-level laser therapy (LLLT) can aid in wound healing. In mice, this laser treatment accelerated the healing of pressure ulcers, closing wounds in about 18 days. Some studies found that specific laser wavelengths, such as 658-nm, effectively helped wounds close, achieving about 70% closure. Another study demonstrated that LLLT significantly improved ulcer size and scar formation. However, one review found no clear benefit for venous leg ulcers specifically, suggesting that results can vary. This trial will compare the effects of Summus Laser treatment, which uses infrared light, with a Sham Summus Laser treatment that does not use infrared light, to evaluate their effectiveness on venous leg ulcers. ^{1 4 5 6 7}

Who Is on the Research Team?

Joseph Molnar, MD

Principal Investigator

WFUHS

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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-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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-ulcer-6-2018-c014b

Laser Therapy for Venous Leg Ulcers Near-infrared low-level laser therapy (LLLT) significantly accelerates the healing of pressure ulcers in mice, achieving complete wound closure in about 18 days ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10796615/

Laser therapy for venous leg ulcers Reviewer's conclusions: We have found no evidence of any benefit associated with low level laser therapy on venous leg ulcer healing. One small study suggests ...

3. medical.summuslaser.com medical.summuslaser.com/data/files/210/1613147389_J7IKCukLGeapCcG.pdf

Photobiomodulation Therapy for Wound Care Their results noted that the 658-nm laser treatment was most effective (70% closure, P < .05) at promoting wound closure. In contrast, the 808- and 940-nm laser ...

4. journals.cambridgemedia.com.au journals.cambridgemedia.com.au/download_file/9701/4337

Low level laser therapy for healing venous leg ulcers The LLLT group showed statistically significantly better results for ulcer size (p = 0.01), scar formation (p = 0.034), granulation (p ...

5. ctv.veeva.com ctv.veeva.com/study/randomized-controlled-trial-for-treatment-of-pain-and-assessment-of-wound-healing-in-chronic-venous

Randomized Controlled Trial for Treatment of Pain and ... The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.

6. summuslaser.com summuslaser.com/

Summus Medical Laser | Advanced Therapeutic Lasers A non-invasive approach designed to support and promote the body's natural processes. Summus Laser Therapy may help improve overall health.

7. trialx.com trialx.com/clinical-trials/listings/242618/randomized-controlled-trial-for-treatment-of-pain-and-assessment-of-wound-healing-in-chronic-venous-leg-ulcers-using-near-infrared-laser-therapy/

Clinical Research Trial Listing ( Venous Leg Ulcer ) ... The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain ...