Seven diabetic patients (4 males and 3 females) with grade II and III diabetic ulcers.
PBM of ulcer beds (wavelength 660 nm; power 25 mW; fluence 0.6-1.0 J/cm2) and wound margins (wavelength 980 nm; power 200 mW; fluence 4-6 J/cm2) for 15–20 min; intravenous PBM (wavelength 655 nm; power 2 mW; irradiation time 20 min); and laser acupuncture with infrared light (wavelength not provided; 1 J/cm2) for LI-11, LI-6, SP-6, PC-6, ST-36, and GB-34 points. PBM sessions were every other day for 10–15 sessions (route 1) and then twice weekly (route 2) until complete recovery was achieved.
Complete wound closure in an average of 19 sessions, with no reported side-effects and no ulcer recurrence at 6 months. The race nor skin color of the participants was not mentioned; however, images used indicate light-skinned patients were used for the trial.
Sixteen residents (9 females and 7 males) at a nursing home with 21 open wounds, including pressure ulcers, venous ulcers, and diabetic wounds.
Two 80 mW laser clusters with wavelength 785 nm () were used to treat the wound periphery and wound bed. A 50 mW laser probe of the same wavelength treated deeper tissue. Wound margin received a fluence of 2–4 joules (1 min), the wound bed received 1–2 joules (30 seconds), and the eschar received 4–6 joules (2 min). For patients with darker skin tones, the dose around the periphery was increased by 50%. PBM administered 5 times for the first week and 3 times a week for weeks 2 to 9 or until healed. PBM was combined with the Extendicare Wound Prevention and Management Program.
61.9% of open wounds had a reduction in size (>50% wound closure) and 42.8% had complete closure; 23.8% of wounds demonstrated no change. No significant differences between chronic and acute wounds were evident. Skin color nor race of participants was mentioned.
Fourteen patients with a total of 23 diabetic leg ulcers. Group one had 10 ulcers and group two had 13 ulcers. The gender of patients was not mentioned.
All patients received conventional therapy (cleaned and dressed with 1% silver sulfadiazine cream, covered with gauze and bandage) twice a week. Group one received placebo PBM of <1 J/cm2 from a probe with three disabled 660 nm diodes and a resistor added to a fourth diode (<5 mW average power and<1 mW/cm2 irradiance). Group two was treated for 30 s/spot with PBM using a 5 cm2 probe cluster with 36 diodes (32 diodes at 890 nm and 4 diodes at 660 nm) of average power of 500 mW (100 mW/cm2) and fluence of 3 J/cm2.
Ulcers in group one healed rapidly within the first 30 days, while ulcers in group two deteriorated, with 56% more granulation and 72% faster healing rate in group one. By day 90, 58.3% of group two had fully healed ulcers and only one ulcer was fully healed in group 2. Group two ulcers achieved a 90–100% healing, while only a single ulcer attained >90% healing in group two. No side effects were experienced. Skin color nor race of participants was mentioned.
Twenty-three diabetic patients (13 in the PBM group and 10 in the placebo group) with ulcers stage I and II (Wagner scale) with a mean duration of 10 months.
PBM (wavelength 685 nm; fluence 10 J/cm2; density 50 mW/cm2) for 200 s 6 times per week for the first two weeks, then every other day till complete healing. Noncontact mode was used at a distance of 1 cm. All patients received conventional therapy.
The wounds reduced in size and healing time in the PBM study group compared to the placebo group. Ulcers in the PBM group achieved 66.6% complete healing compared to 38.4% in the placebo group. Neither race nor skin color of the participants was mentioned.
Sixty-eight patients (male:female ratio 3 : 1) with type 2 DM with Wagner grade I foot ulcers (34 patients as controls and 34 patients as the study group).
Treatments were performed daily for 15 days (wavelengths not provided; power 60 mW; fluence 2-4 J/cm2; pulse frequency 5 kHz). Only the wound bed and wound edges were irradiated then covered with conventional moist dressing. Offloading took place in patients with plantar pressure.
Significant reduction in ulcer size in the PBM group was noted. The mean reduction in ulcer size was in the PBM-treated group compared to in the control group. The researchers did not mention participant’s skin color/race.
Sixteen patients with type 2 DM (8 patients as control and 8 patients as the study group).
PBM (wavelength 632.8 nm; power 30 mW; fluence 4 J/cm2; irradiation time 80 s) administered for 12 sessions of which 3 were weekly sessions, on alternated days. Pain evaluation after 30 days follow-up. Both groups had the wounds washed with 0.9% saline solution.
Decrease in wound size in study group as compared to the control group. Intense improvement in pain in study group. The average wound area (cm2) before treatments in the control group was , which increased to after 30 days. In the study group, a significant decrease in wound size was noted and patients reported an improvement in pain. The average wound area (cm2) before treatments in the PBM group was , which decreased to after 30 days. The race nor skin color of the participants was not mentioned.
Twenty-eight patients with DM and ulcers on the distal legs or feet were randomized into 3 groups (control group, PBM group, and high-voltage-pulsed current group, HVPC).
Groups were treated for 16 weeks. The control group received standard care and wounds were irrigated with saline and received debridement and application of wound dressings 7 days a week. The HVPC group was treated for 45 min three times a week with an electrical simulator (pulse of 100 pps, 100 μs pulse duration) with standard wound care protocol. The PBM group was treated three times a week at a wavelength of 685 nm, (30 mW, applied at 2 J/cm2 (18 s) on the wound edges in light contact, and 1.5 J/cm2 (14 s) on the wound bed in noncontact mode).
The control group achieved 66% healing, the PBM group achieved 77.7% healing, and the HVPC group achieved 80% healing. There were no significant differences between the three groups (). No significant differences were found for protective sensations between the PBM and the HVPC group (). The race nor skin color of the participants was not mentioned.
Experimental, randomized, controlled, prospective, and interventional clinical case study
Thirty-two patients with type 2 DM and foot and leg ulcers randomized into 4 groups (group 1 control, group 2 PBM group, group 3 essential oil group, and group 4 PBM with essential oil group).
Control group treated daily with conservative treatment (wound cleaned with 0.9% saline and covered with sterile gauze) for 30 days. PBM group treated with conservative therapy and PBM (wavelength 658 nm, power 30 mW, and fluence of 4 J/cm2) using contact mode at equidistant points around and on the wound bed for 80 s, three times a week for a month. Group 3 was treated daily with conservative therapy and 5 mL calendula oil for 30 days. Group 4 was treated with conservative therapy, PBM as per group 2 and calendula oil as per group 3 for 30 days.
No significant changes in ankle-brachial index (ABI) and Doppler readings from onset to end of the study in all groups. Reduction in wound size and pain noted in PBM group ( and , respectively) and in PBM with essential oil group ( and , respectively). Neither race nor skin color of the participants was mentioned.
Thirty patients (male:female ratio 2 : 1) with type 2 DM and Wagner grade I foot ulcers (15 patients as control and 15 patients as the study group).
PBM (wavelength ; power density 50 mW/cm2; fluence 3 J/cm2; irradiation time 60 s) or conventional therapy alone. Daily PBM treatment for 15 days. Control group only treated with conventional therapy including daily wet saline or betadine dressings, antibiotic treatment, contact cast immobilization, and slough excision as and when required. Pressure offloading was carried out in patients with plantar ulcers.
The reduction in ulcer area was (30-50% wound area reduction observed in 75% of patients) in the PBM group compared to in the control group (80% of wounds showed a wound area reduction of <20%). The study group also showed increased granulation tissue. The results show significant benefits in patients treated with PBM over patients not treated with PBM. No adverse events and side effects were reported. Skin color nor race of participants was mentioned.
Sixty patients with chronic diabetic ulcers (30 patients in the active group and 30 patients in the control group).
The active group was treated with pulsed wave-modulated LED (wavelength 625 nm, 660 nm and 850 nm; fluence 2.4 J/cm2) for 5 min. The control group received placebo LED (broadband wavelength of 580 nm to 900 nm; fluence 0.72 J/cm2) for 5 min. Patients were treated three times a week for 8 weeks at a distance of 10 cm from the wound. Both groups received conventional therapy (debridement, moist wound bed, and infection control).
Improvement in wound bed granulation and reduced fibrin and eschar. Faster (insignificant) healing rate observed in PBM group. Race nor skin color of the participates was mentioned.
Sixty-five patients (51 males and 14 females) aged 45-60 years and with DFUs classified as grade I and II (Wagner scale).
Patients randomly assigned to two groups; group I received PBM using a helium-neon laser (632 nm, peak power of 20 mW, pulse frequency of 25 Hz, and power density of 15 mW/cm2, surface area with 90 s application/cm2, and dose of 5 J/cm2) and conventional wound care (dressings with wet betadine or saline, antibiotics, and debridement if necessary). Group II received PBM at a wavelength of 904 nm (peak power of 20 mW, pulse frequency of 25 Hz, power density of 40 mW/cm2, spot size of 1 cm2; time of application was determined according to the surface area with 90 s/cm2 and dose of 6 J/cm2) and conventional care.
There was a significant reduction in ulcer size in both groups at 4 and 8 weeks with no significant differences between the groups. Group I had a baseline ulcer size (cm2) of , with ulcer sizes of and after 4 and 8 weeks, respectively, while group II had a baseline ulcer size (cm2) of with ulcer sizes of and after 4 and 8 weeks, respectively. Race nor skin color of the participates was mentioned.
One hundred patients (31 males and 19 females in control; 26 males and 24 females in study group) with diabetic foot ulcers (50 patients as control and 50 as the study group) and Wagner grade I and II foot ulcers.
PBM (wavelength 660 nm; fluence 4-8 J/cm2; irradiation time 20 min) daily for 15 days. Control group treated with conventional treatment only including dressings with betadine or wet with saline, antibiotic treatment and slough removed when necessary.
Reduction in mean area of ulcers at day 15 was noted in the PBM group compared to the control group. There was 66% complete wound healing in participants with grade I ulcers and 96.6% grade II ulcers improved to grade I. The race nor skin color of the participants was not mentioned.
Eighteen patients aged 30–59 years old, with chronic noninfected diabetic foot ulcers, randomized into two groups (control group and the laser group).
Control group was treated with conventional treatment (cleansed wound bed with 0.9% physiological solution and 2 mg hydrogel, covered with gauze and bandage) every 2 days for four weeks. Laser group treated with conventional therapy and PBM (660 nm, power density of 30 mW, and fluence of 6 J/cm2) every 2 days for 4 weeks.
The PBM-treated group had a significant increase in tissue repair index. Average final area in the control group was 1.63cm2 compared with 0.32 cm2 in the PBM group. The skin color nor race of participants was mentioned.
Prospective, randomized comparative clinical study
Twelve participants with chronic diabetic ulcers randomized into two groups (the laser group and the LED group).
Laser group treated with a GaAIAs laser (wavelength 830 nm; power 30 mW; density 0.25 W/cm2; fluence 7 J/cm2; contact mode). LED group treated with LED (wavelength 850 nm; power 48 mW; density 1.05 W/cm2; fluence 4.49 J/cm2, contact mode). The study took place over 6 months, with sessions twice a week and patients were observed at the end of the 10th session.
Drastic wound reduction size in laser treated group as compared to the LED group; 81% wound reduction compared to 62%. Both groups displaced a decrease in neuropathic symptom scores. The race nor skin color of the participants was not mentioned.
An 84-year-old Chinese female patient with type 2 DM and diabetic leg ulcers present for three weeks.
B-cure laser pro and conventional treatment were in place. PBM was self-administered at home. The device emitted infrared light at 808 nm (power output 250 mW; surface area 4.5 cm2; power density 55.5 mW/cm2; frequency 15 kHz; energy 14.4 J per minute; fluence 3.2 J/cm2 per minute; total fluence 48 J/cm2). The treatment was administered daily in two sessions for 15 min.
After one week of treatment the smallest ulcer dried while the larger ulcer was completely healed after thirty days.
