Low Level Laser Therapy for the Treatment of Diabetic Foot Ulcers: A Critical Survey

Table 2

Clinical trials on leg ulcer treatment with LLLT in diabetic ulcers.

Study	Study design	Participants	Intervention	Outcome measures	Treatment outcome
Schindl et al., 1998 [13]	Randomized, double-blinded, placebo- controlled trial	30 diabetic subjects with foot ulcer/gangrene	Single treatment HeNe laser 632.8 nm, 30 J/cm^2 , 50 min	Temperature	Increase of microcirculation due to athermic laser irradiation
Schindl et al., 1999 [14]	Case studies	20 patients with diabetes (𝑛=8), arterial insufficiency (𝑛=5), radio damage (𝑛=4), and autoimmune vasculitis (𝑛=3)	30 mW helium neon laser 632.8 nm, 30 J/cm^2, 3 times weekly, 16–24 weeks until wound closure	Necessary treatments until wound closure	Ulcers due to radio damage healed significantly faster than those caused by diabetes autoimmune vasculitis and required lower time than that in radiodermatitis (nonsignificant);wound size was a predicting parameter but not wound depth and prior treatment
Saltmarche, 2008 [15]	Prospective comparative clinical trial	21 open wounds and 4 “at risk” closed areas, and chronic (> or =3 months) and acute (<3 months) ulcers due to pressure, venous insufficiency, and diabetes	5 times per week in first week, 3 times a week for more 8 weeks, 785 nm	Reduction of size	61.9% of open wounds had significant reduction of size, 42.8% had 100% closure, 14.3% had some improvement, and 23.8% had no change no significant difference between chronic and acute wounds
Zhou et al., 2008 [16]	Randomized, molecular-biological analysis	60 patients with 84 chronic dermal ulcers in diabetes patients and others	Daily till healing Helium neon (HeNe) laser, 632.8 nm	Healing rate, immunohistochemical analysis: HSP70, HSF1	Expression of HSF1, HSP70, and RNA levels of HSF1 and HSP70 in laser group was significantly higher
Minatel et al., 2009 [17]	Randomized, placebo-controlled, double-blinded trial	14 patients with 23 chronic diabetic ulcers	Twice a week till healing, at most 90 days, 660 nm and 890 nm, 3 J/cm^2, 30 sec/5 cm^2	Healing rate and granulation	Treatment group had more granulation (day 30: 56%) and faster healing (day 30: 79.2%), 58.3% healed fully (1 ulcer placebo group); 75% ulcer healed 90–100% day 90 (one ulcer placebo group)
Kaviani et al., 2011 [18]	Randomized, placebo-controlled, double-blinded trial	23 patients, diabetic foot wounds for at least three months	2 times a week for 2 weeks then every second day till healing, 685 nm, 10 J/cm^2  200 sec	Reduction of ulcer size and healing time	Significant reduction of ulcer size of 58±10.4%   in laser group to 23.5±14.1%   two weeks after treatment; healing time of treatment group: 11 weeks, placebo: 14 weeks, but not significant
Kajagar et al., 2012 [19]	Randomized controlled trial	68 patients with chronic diabetic foot ulcers, conventional care + LLLT (𝑛=34) versus conventional care alone	Daily treatment for 15 days, 2–4 J/cm^2  Power, 60 mW Frequency, 5 kHz	Ulcer size	Significant reduction of percentage of ulcer area LLLT group
Landau et al., 2011 [20]	Randomized, placebo-controlled, double-blinded trial	14 patients with diabetic ulcers, 2 patients with venous ulcers	Twice daily for 12 weeks broadband (400–800 nm) 43.2 J/cm^2,  4 minutes	Healing rate Reduction of size Wound closure time	Treatment group Healing: 90%, reduction of size: 89%, mean/median Wound closure time: 7.14/11.16 weeks Placebo group Healing: 33%, reduction of size: 54%, mean/median Wound closure time: 11.5 weeks