Laser Therapy for Foot Ulcers

(LLL&DIAB-02 Trial)

Overseen By Rose Raizman, MSc, MScN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scarborough Rouge Hospital

Must not be taking: Immunosuppressants

Disqualifiers: Active malignancy, Anemia, Uncontrolled hyperglycemia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-use laser device, the B-Cure Laser Pro, to determine if it accelerates the healing of diabetic foot ulcers compared to standard treatments alone. Diabetic foot ulcers are persistent wounds that can be difficult to manage and often affect daily life. Participants will use either the real laser device or a sham version (a placebo device that looks identical but lacks the laser effect) while continuing their usual care routine. Individuals with type 1 or type 2 diabetes who have had a foot ulcer for at least three months may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore new treatment options for diabetic foot ulcers.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking immunosuppressive medication or have received certain growth factor therapies recently, you may not be eligible to participate.

What prior data suggests that this laser device is safe for treating diabetic foot ulcers?

Research has shown that the B-Cure Laser Pro is generally safe for treating diabetic foot ulcers. This low-level laser therapy uses light treatment that neither cuts, burns, nor heats, making it a non-invasive and painless option. In previous studies, patients who used the B-Cure Laser Pro daily for 12 weeks experienced significant wound reduction, with no major side effects reported. The device is designed for home use, providing convenience without compromising safety. Overall, evidence suggests that people tolerate the B-Cure Laser Pro well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for foot ulcers, which often involve topical medications, dressings, and sometimes surgery, the B-Cure Laser Pro offers a unique approach by using low-level laser therapy (LLLT). This device allows patients to self-treat at home, potentially increasing convenience and adherence to treatment protocols. Researchers are excited because this non-invasive method may accelerate healing by stimulating cellular repair processes, offering a promising alternative for quicker and more effective relief from foot ulcers.

What evidence suggests that the B-Cure Laser Pro is effective for diabetic foot ulcers?

Research has shown that low-level laser therapy, such as the B-Cure Laser Pro, can accelerate the healing of diabetic foot ulcers (DFUs). In this trial, participants in one arm will use the B-Cure Laser Pro daily. Studies have found that this device can significantly reduce ulcer size. Specifically, one study revealed that patients who used the B-Cure Laser Pro daily for 12 weeks experienced better healing than those who did not. This treatment aids wound healing, making it a promising option for individuals with DFUs. Overall, evidence suggests that the B-Cure Laser Pro is an effective and non-invasive tool for treating these challenging wounds. ^{1 2 3 4 6}

Who Is on the Research Team?

Rose Raizman, MSc, MScN

Principal Investigator

Scarborough Health Network

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 with Type 1 or Type 2 diabetes and a diabetic foot ulcer that's lasted at least 3 months. They must have good blood flow in their legs and be able to change dressings. Women who can have children must use effective birth control. People with severe anemia, uncontrolled diabetes, recent cancer treatments, or those using immunosuppressants cannot join.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or Female

Exclusion Criteria

Anemia (Hb<8 gr/dL)

You have a device at home that uses low-level laser therapy.

HbA1c > 12% (uncontrolled hyperglycemia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard treatment and self-treat at home daily with either the active B-Cure laser device or a sham device

12 weeks

Visits every 2 weeks for wound evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• B-Cure Laser Pro
• Sham laser

Trial Overview The study tests the B-Cure Laser Pro device against a sham laser to see if it speeds up healing of diabetic foot ulcers when used at home along with standard care. Participants will randomly receive either the real or sham treatment.

How Is the Trial Designed?

Group I: B-Cure Laser Pro Experimental Treatment 1 Intervention

Subjects from the B-Cure Laser Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device.

Group II: Sham laser Placebo Group 1 Intervention

Subjects from the Sham laser group will receive standard care and in addition will self-treat at home daily with the sham B-Cure device.

B-Cure Laser Pro is already approved in Canada for the following indications:

Approved in Canada as B-Cure Laser Pro for:

• Diabetic foot ulcers
• Chronic pain
• Orthopedic conditions
• Sports injuries
• Wounds

Who Is Running the Clinical Trial?

Scarborough Rouge Hospital

Lead Sponsor

Trials

4

Recruited

510+

Published Research Related to This Trial

In a study involving 23 patients with diabetic foot ulcers, low-level laser therapy (LLLT) significantly reduced ulcer size after 4 weeks compared to a placebo, indicating its potential effectiveness in promoting wound healing.

After 20 weeks, more patients in the LLLT group achieved complete healing (8 out of 13) compared to the placebo group (3 out of 10), suggesting that LLLT may accelerate the healing process for chronic diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Kaviani, A., Djavid, GE., Ataie-Fashtami, L., et al.[2015]

In a placebo-controlled double-blind study involving 10 patients with diabetic foot or chronic leg ulcers, 90% of those treated with broadband visible light (400-800 nm) had their wounds completely closed after 12 weeks, compared to only 33% in the placebo group.

The treatment group experienced an average wound size reduction of 89%, while the placebo group saw only a 54% reduction, indicating that broadband light therapy is a promising and effective option for treating non-healing ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visible light-induced healing of diabetic or venous foot ulcers: a placebo-controlled double-blind study. Landau, Z., Migdal, M., Lipovsky, A., et al.[2011]

Photobiomodulation therapy (PBMT) using a 658 nm laser demonstrated significant effectiveness in achieving complete wound healing for pressure ulcers compared to other laser wavelengths, with a statistically significant result (P < 0.001).

Despite showing efficacy in healing, PBMT did not significantly reduce the time to complete wound healing or the area of the ulcers compared to standard care, indicating that while it is effective, it may not be faster than traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Photobiomodulation on Repairing Pressure Ulcers in Adult and Elderly Patients: A Systematic Review. Petz, FFC., Félix, JVC., Roehrs, H., et al.[2021]

Low-level laser therapy (LLLT) significantly improved clinical scores in dogs with sterile pyogranulomatous pododermatitis, showing better results compared to a control treatment with hydrocortisone aceponate after 4 days and 20 days.

Over 50% of the lesions treated with LLLT did not recur after 2 months, and no adverse reactions were reported, indicating that LLLT is a safe and effective option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy: Case-control study in dogs with sterile pyogranulomatous pododermatitis. Perego, R., Proverbio, D., Zuccaro, A., et al.[2020]

Photobiomodulation (PBM) therapy, using specific wavelengths of light, has been shown to improve healing rates for diabetic foot ulcers (DFUs) compared to standard wound care, based on a review of 13 studies involving 417 participants.

Despite the positive outcomes, the studies had limitations such as small sample sizes and inconsistencies in laser protocols, indicating a need for further research to solidify PBM's efficacy and optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and diabetic foot and lower leg ulcer healing: A narrative synthesis. Sutton, E., Ganie, S., Chan, C., et al.[2021]

Low-level laser therapy (LLLT) significantly improved the healing of diabetic foot ulcers, with a 37% reduction in wound area compared to only 15% in the control group receiving conventional therapy alone, based on a study of 30 patients with type 2 diabetes.

Approximately 75% of patients receiving LLLT experienced a wound area reduction of 30-50%, indicating that LLLT is an effective adjunct treatment for enhancing wound healing in diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy as an adjunct to conventional therapy in the treatment of diabetic foot ulcers. Mathur, RK., Sahu, K., Saraf, S., et al.[2018]

Low-level laser therapy (LLLT) significantly reduces the size of diabetic foot ulcers (DFUs), as shown in a meta-analysis of 13 randomized controlled trials involving 361 participants, with a notable reduction of 22.96% in ulcer size compared to control groups.

The effective LLLT parameters identified include wavelengths of 632.8 to 685 nm, power density of 50 mW/cm2, energy density of 3 to 6 J/cm2, and treatment duration of 30 to 80 seconds, applied three times weekly for a month, indicating that LLLT is both effective and safe for DFU treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of the Effects of Low-Level Laser Therapy in the Treatment of Diabetic Foot Ulcers. Santos, CMD., Rocha, RBD., Hazime, FA., et al.[2022]

Low-level laser therapy (PBMT) significantly accelerates the healing of chronic diabetic foot ulcers (DFUs), with a mean closure time of 26 days observed in a study of 17 patients with type 2 diabetes.

The treatment also improved neuropathic symptoms, as indicated by a notable reduction in vibration pressure threshold, suggesting that PBMT combined with structured foot care can enhance overall foot health in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy in neuroischaemic diabetic foot ulcers: a novel method of limb salvage. Maiya, AG., Kumar, AS., Hazari, A., et al.[2019]

In a study involving 138 patients with recurrent aphthous stomatitis (RAS), Nd:YAG laser therapy significantly reduced pain and lesion size compared to a placebo, demonstrating its efficacy in managing RAS lesions.

Both focused and defocused laser techniques were effective, with focused laser providing a higher energy density, suggesting that laser parameters can be adjusted for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of recurrent aphthous ulcers with therapeutic Nd:YAG laser, using two different methods. Fekrazad, R., Gholami, GA., Sadr Eshkevari, P., et al.[2023]

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]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01493895

Study Assessing Safety and Efficacy of B-cure Laser ... This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers. Conditions. Diabetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9789897/

Clinical Effect of Photobiomodulation on Wound Healing ... All the clinical trials adopted for this review show evidence that PBM together with conventional treatment results in an increased healing rate of DFUs.

3. bcurelaser.com bcurelaser.com/clinical-trials/

B-Cure Laser's Clinical Trials 12 weeks of daily B-Cure Laser Pro treatments have significantly decreased wound size in patients with diabetic foot ulcers compared to sham irradiated controls ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/412979

Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers Photobiomodulation (low level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002974

Dose-response and efficacy of low-level laser therapy on ... Current evidence shows that low-level laser therapy (LLLT) is an effective non-invasive and non-pharmacological strategy to treat diabetic foot ulcers (DFU).

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958259221000730

Photobiomodulation and diabetic foot and lower leg ulcer ... Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), is a non-invasive and painless therapy that does not cut, ablate, or produce heat [6].