שנה שפה:

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



Amir Haze, Ofer Elishoov, Dorit Shorka, Tamir Tsohar, Meir Liebergall
Orthopedic Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel

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.

העלאת קובץ המאמר או המצגת

Dr. Amir Haze