Healing of Chronic Diabetic Foot Ulcers Using B-Cure Laser Pro- Low Level Laser Therapy

Background: Diabetes mellitus (DM) is a significant health concern affecting hundreds of millions individuals worldwide. A diabetic person has a 25% lifetime risk of developing a diabetic foot ulcer (DFU), which may lead to limb amputation and risk patient`s life. The cellular and molecular effects of LLLT on wound healing were studied, though solid clinical effects on DFU healing is still lacking. The current study is a double blinded randomized trial evaluating the effects of a home use LLLT device (B-cure laser Pro, Israel) on DFU healing.

Methods: 19 patients, suffering for at least 6 weeks from a DFU, sized 3-37.5cm² were recruited. Patients were randomly assigned to daily treatments of LLLT (808nm, 8 minutes, 9 J/cm²) (experimental group, n=10) or sham (control group, n=9) in addition to standard of care dressing. The treatment period lasted 12 weeks or until wound closure.

Results: Initial wound sizes were 11.2±11.1cm² in the control group and 12.4±9.2 in the experimental group. At the endpoint wound sizes were 6.5±7.3 and 1.5±2.4 respectively. Using 2-sided exact Wilcoxon Sign Ranks test no significant difference was found between the initial wound sizes of the groups (p=0.92) and also between the initial and final wound sizes in the control group (p=0.301). Significant difference was found between the initial and final wound sizes in the experimental group (p=0.002). Direct comparison of percentage of wound closure between the experimental and control groups showed a significant healing effect of laser over sham (p=0.033).7 of 10 B-cure patients vs 1 of 9 placebo patients had >90% wound closure (p=0.019 by Fisher Exact Probability Test).

Conclusions: In spite of the relatively small groups the results show that B-cure laser Pro may be beneficial as an adjunctive treatment to standard care for DFU healing. Further studies are warranted to strengthen our conclusions.