Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial.

PURPOSE: This study aimed to examine the impact of a 904 nm photobiomodulation (PBM) on diabetic ulcers using varying dosages. METHODS: The study was a randomized, double-blind, placebo-controlled clinical trial that compared treatments using PBM (GaAs 904 nm 30w) with three different energy densities (4 J/cm2; 8 J/cm2; 10 J/cm2) in the healing process of non-infected diabetic foot ulcers. Eighty volunteers (48.75% female; 58.5 ± 11.1 years) were randomized into three intervention groups treated with PBM and one control group (PBM placebo). Volunteers performed up 20 interventions with PBM, either placebo or actual, in conjunction with conventional therapy, which involved dressing the wound with Helianthus annuus vegetable oil. The primary variable was the ulcer size reduction rate. RESULTS: GaAs 904 nm PBM yielded a clinically and significant ulcer size rate reduction of diabetic foot ulcers, independently of energy density range (p < 0.05). However, 10 J/cm² had 60% of completely healed ulcers and the highest proportion of patients reaching 50% of ulcer reduction rate after 5 weeks of treatment. In addition, only 10 J/cm² showed a significant difference between control group after a 10-week follow-up (p < 0.05). CONCLUSION: GaAs 904 nm PBM was effective in treating diabetic foot ulcers in this study and a dosage of 10 J/cm², after a 10-week follow-up, proved to be the most effective compared to the other groups. CLINICAL TRIAL REGISTRATION NUMBER: NCT04246814.

Efeitos da laserterapia em pacientes com pé diabético / Effects of laser therapy on patients with diabetic foot

Introdução: As úlceras de pé diabético representam uma importante causa de amputações não-traumáticas. A terapia com laser de baixa intensidade tem demonstrado bons resultados ao acelerar a cicatrização de feridas crônicas, sobretudo em condições de microcirculação reduzida. Portanto, o objetivo do estudo é avaliar os efeitos da laserterapia no tratamento dos pacientes com pé diabético.Metodologia: Tratou-se de uma revisão sistemática de estudos contidos nas bases de dados eletrônicos PubMed, LILACS e SciELO, sem restrição de ano, utilizando os descritores "Diabetes mellitus", "Hiperglicemia", "Lasers", "Pé diabético", "Lesão por pressão" nas línguas inglesa e portuguesa. Foram excluídos os estudos não-randomizados, relatos de caso, observações clínicas e revisões. A Cochrane Collaboration foi utilizada para analisar a qualidade metodológica dos estudos.Resultados: Foram encontrados 24 artigos, sendo excluídos 18 por não se adequarem ao objetivo do estudo. Os estudos trazem um resultado estatisticamente significativo da utilização do LLLT no processo de cicatrização das úlceras diabéticas. Apenas um estudo não teve relevância estatística quando comparado ao grupo controle. Ainda assim, todos os autores apresentam eficácia dessa conduta, mesmo de forma indireta.Conclusão: O uso da laserterapia é uma intervenção que promove efeitos importantes na melhora da cicatrização das feridas em pacientes com úlceras diabéticas. No entanto, não há congruência na literatura de quais são os parâmetros mais adequados para aplicação dessa técnica.

Introduction: Diabetic foot ulcers are a major cause of nontraumatic amputations. Low-level laser therapy (LLLT) has shown good results in accelerating chronic wound healing, especially in conditions of reduced microcirculation. Therefore, the objective this study was evaluate the effects of LLLT on the treatment of patients with diabetic foot.Methodology: We conducted a systematic review in the electronic databases PubMed, LILACS, and SciELO, with no restrictions on date of publication. The following terms were used: "Diabetes Mellitus", "Hyperglycemia", "Lasers", "Diabetic Foot", and "Pressure Ulcer", in English and Portuguese. We excluded nonrandomized studies, case reports, clinical observations, and reviews. The Cochrane Collaboration was used to evaluate the methodological quality of the studies.Results: The search yielded 24 articles, of which 18 were excluded because they did not fit the study objective. Study results on the use of LLLT for diabetic ulcer healing were statistically significant. Only one study had no statistical significance when compared to the control group. Still, all studies showed LLLT to be effective, even if indirectly.Conclusion: The use of LLLT promotes important effects on the improvement of wound healing in patients with diabetic ulcers. However, there is no consensus on the literature regarding the best parameters to apply this technique.

Diabetic Foot Wounds Treated With Human Amniotic Membrane and Low-level Laser Therapy: A Pilot Clinical Study.

BACKGROUND: Low-level laser therapy (LLLT) and human amniotic membrane (HAM) application have been shown to be viable options for use in wound healing. PURPOSE: This study sought to compare LLLT and HAM to a control treatment (hydrogel, saline, and gauze) in persons with diabetes mellitus (DM) and foot ulcers. METHODS: Using a prospective pilot clinical study design, patients receiving care at a health center that specializes in the treatment of diabetic foot wounds between November 2016 and August 2017 were recruited. Eligible patients had to be 30 to 59 years of age; diagnosed with type 2 DM (postprandial capillary glucose levels between 140 and 350 mg/dL); and have uninfected, granulating stage 2 or 3 foot ulcers measuring less than 7 cm by 3 cm. Immunosuppressed and malnourished patients or those with neoplasms or in critical condition were not eligible to participate. Patients received the control treatment (2 mg hydrogel, saline, and gauze), HAM (patches of thawed HAM, applied with overlapping edges), or LLLT (phototherapy session, 2 mg hydrogel, saline, and gauze) for 28 days. Variables, wound area measurements, Pressure Ulcer Scale for Healing (PUSH) scores, and Visual Analog Scale (VAS) scores were used to assess wound improvement progress and pain on days 7, 14, 21, and 28. Descriptive statistics were used to analyze the participant anthropometric and clinical profiles. The Kolmogorov-Smirnov test was used to analyze the sample distribution. The Kruskal-Wallis test with Dunn's post-test was used to evaluate differences in PUSH and VAS scores and wound size for intergroup analysis, and the Mann-Whitney U test was used for the same outcomes in intragroup analysis. The level of significance was 5% (P < .05). RESULTS: Twenty-seven (27) patients participated (mean age, 51.4 years; mean body mass index, 26.5 kg/m2), with 9 patients in each treatment group. No statistically significant differences were noted in clinical or anthropometric variables among the groups, but mean baseline wound areas were different (2.6 cm² for the control, 1.9 cm² for the LLLT, and 5.5 cm² for the HAM groups). Intragroup comparisons showed a significant reduction in PUSH score in the LLT group between days 0 and 21 (8.2 vs 4.9; P < .01) and days 21 to 28 (4.9 vs 3.2; P < .001). In all treatment groups the percent reduction was significantly different between days 7 and 28. No outcomes were significantly different between groups. CONCLUSION: Diabetic foot ulcer wound area as well as PUSH and VAS scores showed more improvement for patients with DM receiving LLLT or HAM than for the control group, but the differences were not significant. Larger studies are needed to compare these treatment modalities.

A Systematic Review and Meta-Analysis of the Effects of Low-Level Laser Therapy in the Treatment of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) are considered one of the most aggressive and expensive complications of diabetes. Low-level laser therapy (LLLT) has been highlighted as a potential modality of treatment to accelerate the healing of ulcers. This systematic review and meta-analysis aimed to investigate the efficacy of LLLT in the treatment of DFU and identify the LLLT application parameters recommended for the treatment of DFU over the past 10 years. A systematic search was conducted in PubMed, BVS, PEDro, Scopus, Web of Science, and CINAHL up to March 31, 2019. Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines, randomized controlled trials (RCTs) that assessed the effect of LLLT on the treatment of DFU were included. Thirteen RCTs with a total of 361 participants were included in this review. Three RCTs reported a reduction in the percentage size of the ulcers and were included in the meta-analysis. The meta-analysis of the percentage size difference demonstrated a significant reduction in ulcer size in the LLLT group compared with controls (22.96 [95% confidence interval = 18.22-27.69; z = 9.51, P < .0001]). Treatment with 632.8 to 685 nm, 50 mW/cm2, 3 to 6 J/cm2, and irradiation for 30 to 80 seconds, 3 times weekly for a month is of benefit to patients with DFU. LLLT is effective and safe for the treatment of DFU. Additionally, well-designed, high-quality studies are needed to allow its ideal parameterization for clinical practice.

Photobiomodulation: systematic review and meta-analysis of the most used parameters in the resolution diabetic foot ulcers.

The most common photobiomodulation parameters used to aid in the treatment of diabetic foot ulcers were investigated in this paper. The databases MEDLINE, LILACS, MEDCARIB, PAHO-IRIS, and WHOLIS were searched with the following descriptors: diabetic foot ulcers AND low-level laser therapy OR low-level therapy AND wound healing; this search was conducted from January of 2014 to December of 2019. Inclusion criteria were randomized clinical trials on humans. Exclusion criteria were systematic reviews, literature reviews, studies with animals, studies lacking photobiomodulation parameters, and studies with non-diabetic individuals. The Jadad scale was used in order to analyze the methodological quality of the matching papers. There were seventeen studies found on PubMed and four on LILACS. Among these, seven were selected, according to the inclusion and exclusion criteria. Two out of the seven matching studies obtained a high score, and five obtained a low score, on the Jadad scale. The studies settled on the use of 600-nm and 800-nm wavelength spectrum. Most of the analyzed papers on photobiomodulation on diabetic foot ulcers did not describe the detailed parameters in their methodology. None of the studies featured the maximum score with regard to the Jadad scale for methodological quality. The relations of energy versus wavelength and power versus wavelength were divergent among the parameters on the papers. Therefore, it is necessary to analyze the parameters for an optimized power value in order to improve the results of the treatment.

Effects of Low-Power Light Therapy on the Tissue Repair Process of Chronic Wounds in Diabetic Feet.

OBJECTIVE: To analyze the efficacy of the therapeutic use of Low-Level Laser Therapy (LLLT) on the tissue repair process of chronic wounds in patients with diabetic feet through the analysis of Pressure Ulcer Scale for Healing (PUSH) scales, pain and the measurement done using the ImageJ© software. METHODS: This clinical trial was carried out with 18 patients 30-59 years of age, who had chronic wounds on their foot due to complications of diabetes mellitus. The patients were randomly allocated in two different groups of equal numbers: Control and Laser Groups. The LLLT equipment used in the research has a wavelength of 660 nm, 30 mW power, continuous mode emission, 6 J/cm2 dosimetry, 48/48 h in a 4-week period. Measurement and the aspect of wounds were noted in the PUSH scale and the pain was evaluated weekly. The Mann-Whitney U nonparametric test was used to compare groups. RESULTS: The Laser Group presented a significant increase of the tissue repair index when compared with the Control Group, with a significant statistical difference (p < 0.013). There was no significant difference between the groups in all the weeks using the PUSH scale. CONCLUSIONS: The use of LLLT on chronic wounds in a diabetic foot demonstrated efficacy on the progression of the tissue repair process in a short period.

Laser therapy in wound healing associated with diabetes mellitus - Review.

OBJECTIVE: To determine the most effective parameter in healing wounds related to diabetes mellitus, as well as the most widely used type of laser. METHODOLOGY: consisted of bibliographic searching the databases Bireme, SciELO, PubMed/Medline and Lilacs by using the keywords related to the topic. Were selected from these keywords, papers discussing the use of laser on wounds associated with diabetes, published in the period 2005-2014, in Portuguese or English. RESULTS: After analyzing the research, 12 studies consistent with the theme were selected. CONCLUSION: Based on this review, the studies that showed more satisfactory results in healing diabetic wounds were those who applied energy densities in the range of 3-5 J/cm2, power densities equal to or below 0.2 W/cm2 and continuous emission. The He-Ne laser with a wavelength of 632.8 nm was used more often.

Laser therapy in wound healing associated with diabetes mellitus - Review

Abstract: The article discusses the results of a literature review on the application of low intensity laser therapy on the healing of wounds associated diabetes mellitus in the last 10 years. Objective: To determine the most effective parameter in healing wounds related to diabetes mellitus, as well as the most widely used type of laser. Methodology: consisted of bibliographic searching the databases Bireme, SciELO, PubMed/Medline and Lilacs by using the keywords related to the topic. Were selected from these keywords, papers discussing the use of laser on wounds associated with diabetes, published in the period 2005-2014, in Portuguese or English. Results: After analyzing the research, 12 studies consistent with the theme were selected. Conclusion: Based on this review, the studies that showed more satisfactory results in healing diabetic wounds were those who applied energy densities in the range of 3-5 J/cm2, power densities equal to or below 0.2 W/cm2 and continuous emission. The He-Ne laser with a wavelength of 632.8 nm was used more often.

Effects of the Low-Level Laser Therapy (LLLT) in the process of healing diabetic foot ulcers

ABSTRACT PURPOSE: To evaluate the effects of the low-level laser therapy applying Laser on the tissue repair in ulcer carriers due to diabetes. METHODS: Sixteen type II diabetic patients, ulcer carriers in the lower limbs, participated in the research from which eight were in the control group and eight were submitted to the low-level laser therapy with a pulsed wave form, visible ray, wave length of 632.8 nm, 30 mW peak power, (Laser - HTM). The application time was of 80 (4J/cm2) seconds. The application was punctual without contact (approximately 1mm of distance), the pen being held in a perpendicular position related to the wound, in equidistant points. There were 12 appointments, of which three were done weekly in alternated days. Photograph records and an application of the brief inventory of pain were done before and after 30 days of follow-up. RESULTS: There was a significant decrease in the size of the wound when compared to the control group (p<0.05). The pain was also reported as having an intense improvement in the treated group. CONCLUSION: The low-level laser treatment seems to be an efficient method, viable, painless and of low costs concerning the tissue repair ulcers in a diabetic foot.

Effects of the Low-Level Laser Therapy (LLLT) in the process of healing diabetic foot ulcers.

PURPOSE: To evaluate the effects of the low-level laser therapy applying Laser on the tissue repair in ulcer carriers due to diabetes. METHODS: Sixteen type II diabetic patients, ulcer carriers in the lower limbs, participated in the research from which eight were in the control group and eight were submitted to the low-level laser therapy with a pulsed wave form, visible ray, wave length of 632.8 nm, 30 mW peak power, (Laser - HTM). The application time was of 80 (4J/cm2) seconds. The application was punctual without contact (approximately 1mm of distance), the pen being held in a perpendicular position related to the wound, in equidistant points. There were 12 appointments, of which three were done weekly in alternated days. Photograph records and an application of the brief inventory of pain were done before and after 30 days of follow-up. RESULTS: There was a significant decrease in the size of the wound when compared to the control group (p<0.05). The pain was also reported as having an intense improvement in the treated group. CONCLUSION: The low-level laser treatment seems to be an efficient method, viable, painless and of low costs concerning the tissue repair ulcers in a diabetic foot.