Photobiomodulation using red and infrared spectrum light emitting-diode (LED) for the healing of diabetic foot ulcers: a controlled randomized clinical trial.
Diabetes mellitus
Diabetic foot
Photobiomodulation
Phototherapy
Wound healing
Journal
Lasers in medical science
ISSN: 1435-604X
Titre abrégé: Lasers Med Sci
Pays: England
ID NLM: 8611515
Informations de publication
Date de publication:
09 Oct 2024
09 Oct 2024
Historique:
received:
05
12
2022
accepted:
23
09
2024
medline:
9
10
2024
pubmed:
9
10
2024
entrez:
9
10
2024
Statut:
epublish
Résumé
Assessing the responses to the application of photobiomodulation using red and infrared spectrum light-emitting diodes (LED) on diabetic foot ulcers. Diabetic volunteers, of both genders, aged between 30 and 65 years, with grade I or II ulcers, were randomized into the groups: red LED, infrared LED, LED associated, and control. Home-based interventions took place on a daily basis for 12 weeks. Assessments of sample characterization were performed on day 1 and 90, and the variables wound healing index, mean skin temperature, sensitivity and pain in the wound area were measured at the pre-intervention time on days 1, 30, 60 and 90, with subsequent follow-up 30 days after the end of treatment. For statistical analysis, the software SPSS, version 17.0, intention-to-treat analysis, data normality was tested, and the linear mixed effects model, with a significance level of 5%. Magnitudes of clinical effect by Cohen's d. At the pre vs post intervention time of 90 days, we found a large clinical effect of G-LED V (d=1.7) and G -LED IV (d=1.6) in relation to G-C, where these intervention groups showed a tendency for faster wound healing compared to G-C. We also observed small clinical effect of G-LED IV, which showed greater reduction in the area in relation to G-LED V (d=0.4) and G-LED A (d=0.3). Conclusion: The use of individually applied red and infrared LED phototherapy clinically tended to be more effective for the reduction of diabetic foot ulcer areas, and infrared LED was the most effective. Trial registration: NCT03250533 (clinicaltrials.gov).
Identifiants
pubmed: 39382587
doi: 10.1007/s10103-024-04199-5
pii: 10.1007/s10103-024-04199-5
doi:
Banques de données
ClinicalTrials.gov
['NCT03250533']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
253Subventions
Organisme : Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
ID : Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Organisme : Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
ID : Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.
Références
Unwin N (2008) The diabetic foot in the developing world. Diabetes Metab Res Rev 24(Suppl 1):S31–S3
doi: 10.1002/dmrr.857
pubmed: 18395867
International Diabetes Federation (2017) IDF Diabetes Atlas, 8th edn. International Diabetes Federation, Brussels, Belgium
Lan CC, Liu IH, Fang AH, Wen CH, Wu CS (2008) Hyperglycaemic conditions decrease cultured keratinocyte mobility: implications for impaired wound healing in patients with diabetes. Br J Dermatol 159:1103–1115. https://doi.org/10.1111/j.1365-2133.2008.08789.x
doi: 10.1111/j.1365-2133.2008.08789.x
pubmed: 18717678
Rüttermann M, Maier-Hasselmann A, Nink-Grebe B, Burckhardt M (2013) Clinical practice guideline: local treatment of chronic wounds in patients with pe ripheral vascular disease, chronic venous insufficiency and diabetes. Dtsch Arztebl Int 110(3):25–31
pubmed: 23413377
pmcid: 3566621
Game FL, Apelqvist J, Attinger C, Hartemann A, Hinchliffe RJ, Löndahl M, Price PE, Jeffcoate WJ (2016) International Working Group on the Diabetic Foot. Effectiveness of interventions to enhance healing of chronic ulcers of the foot in diabetes: a systematic review. Diabetes Metab Res Rev Jan; 32. Suppl1:154 – 68.
Kim WS, Calderhead RG (2011) Is light-emitting diode phototherapy (LED-LLLT) really effective? Laser ther. 20(3):205–215
De Alencar FSJ, Campelo MBD, de Oliveira RA, Nicolau RA, Rezende VEA, Arisawa EAL (2018) Effects of low-power light therapy on the tissue repair process of chronic wounds in Diabetic feet. Photomed Laser Surg 36:298–304. https://doi.org/10.1089/pho.2018.4455
doi: 10.1089/pho.2018.4455
Landau Z, Migdal M, Lipovsky A, Lubart R (2011) Visible light-induced healing of diabetic or venous foot ulcers: a placebo-controlled double-blind study. Photomed Laser Surg Jun 29(6):399–404
doi: 10.1089/pho.2010.2858
Corazza AV, Jorge J, Kurachi C, Bagnato VS (2007) Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources. Photomed Laser Surg 25(2):102–106
doi: 10.1089/pho.2006.2011
pubmed: 17508845
Lau P, Bidin N, Krishnan G, AnaybBaleg SM, Sum MB, Bakhtiar H, Nassir Z, Hamid A (2015) Photobiostimulation effect on diabetic wound at different power density of near infrared laser. J Photochem Photobiol B Oct 151:201–207
doi: 10.1016/j.jphotobiol.2015.08.009
Xavier M, David DR, de Souza RA, Arrieiro AN, Miranda H, Santana ET, Silva JA Jr, Salgado MA, Aimbire F, Albertini R (2010) Anti-inflammatory effects of low-level light emitting diode therapy on Achilles tendinitis in rats. Lasers Surg Med 42(6):553–558
doi: 10.1002/lsm.20896
pubmed: 20662032
Leite GPMF, das Neves LMS, Silva CA et al (2017) Photobiomodulation laser and pulsed electrical field increase the viability of the musculocutaneous flap in diabetic rats. Lasers Med Sci 32:641
doi: 10.1007/s10103-017-2160-7
pubmed: 28155011
Li S, Wang C, Wang B, Liu L, Tang L, Liu D, Yang G, Zhang L (2018) Efficacy of low-level light therapy for treatment of diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract Sep 143:215–224 Epub 2018 Jul 23. PMID: 30009935
doi: 10.1016/j.diabres.2018.07.014
Opel DR, Hagstrom E, Pace AK, Sisto K, Hirano-Ali SA, Desai S, Swan J (2015) Light-emitting diodes: a brief review and clinical experience. J Clin Aesthet Dermatol Jun 8(6):36–44
Minatel DG, Frade MAC, França SC, Enwemeka CS (2009) Phototherapy promotes Healing of Chronic Diabetic Leg Ulcers that failed to Respond to other therapies. Lasers Surg Med 41:433–441
doi: 10.1002/lsm.20789
pubmed: 19588536
Brucki SMD et al (2003) Sugestões para o uso do Mini-exame do Estado Mental no Brasil. Arq Neuropsiquiatr 61(3):777–781
doi: 10.1590/S0004-282X2003000500014
pubmed: 14595482
Meggitt B (1976) Surgical management of the diabetic foot. Br J Hosp Med 16:227–232
Wagner FW Jr (1981) The dysvascular foot: a system for diagnosis and treatment. Foot Ankle 2:64–122
doi: 10.1177/107110078100200202
pubmed: 7319435
Diretrizes da Sociedade Brasileira de Diabetes (2019) Métodos para avaliação do controle glicêmico. São Paulo; AC. Farmacêutica. 2019–2020;75–84
Pedrosa HC (2014) Neuropatia diabética. [E-Book, SBD 2014]. Disponível em: < http://www.diabetes.org.br
Bakker K, Apelqvist J, Lipsky BA et al (2015) The 2015 Guidance on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. International Working Group on the Diabetic Foot (IWGDF). Disponível em: http://www.iwgdf.org
Hinchliffe RJ, Brownrigg JR, Apelqvist J et al (2015) IWGDF Guidance on the diagnosis, prognosis and management of peripheral artery disease in patients with foot ulcers in diabetes. Diabetes Metab Res Rev [in press]
Schaper NC, Andros G, Apelqvist J, Bakker K, Lammer J, Lepantalo M, Mills JL, Reekers J, Shearman CP, Zierler RE, Hinchliffe RJ (2012) Diagnosis and treatment of peripheral arterial disease in diabetic patients with a foot ulcer. A progress report of the International Working Group on the Diabetic Foot. Diabetes Metab Res Rev Feb;28 Suppl 1:218 – 24.
Young MJ, Boulton AJM, Macleod AF, Willians DRR, Sonksen PH (1993) A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia 36:150–154
doi: 10.1007/BF00400697
pubmed: 8458529
Moreira RO, Castro AP, Papelbaum M, Appolina’ rio JC, Ellinger VCM et al (2005) Translation into Portuguese and assessment of the reliability of a scale for the diagnosis of diabetic distal polyneuropathy. Arq Bras Endocrinol Metab 49:944–950
doi: 10.1590/S0004-27302005000600014
Cardinal M, Eisenbud DE, Phillips T, Harding K (2008) Early healing rates and wound area measurements are reliable predictors of later complete wound closure. Wound Rep Reg v 16(1):19–22
doi: 10.1111/j.1524-475X.2007.00328.x
Cardinal M, Eisenbud DE, Armstrong DG (2009) Wound shape geometry measurements correlate to eventual wound healing. Wound Repair Regeneration Saint Louis 17(2):173–178
doi: 10.1111/j.1524-475X.2009.00464.x
Magalhães MF, Dibai-Filho AV, Guirro EC, Girasol CE, de Oliveira AK, Dias FR et al (2015) Evolution of skin temperature after the application of compressive forces on tendon, muscle and myofascial trigger point. PLoS ONE 10:e0129034
doi: 10.1371/journal.pone.0129034
pubmed: 26070073
pmcid: 4466487
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP (2011) Validity of four pain intensity rating scales. Pain 152(10):2399–2404
doi: 10.1016/j.pain.2011.07.005
pubmed: 21856077
De Jesus Guirro RR, de Carvalho G, Gobbi A, de Oliveira Assunção FF, de Souza Borges NC, Bachmann L (2020) Measurement of Physical Parameters and Development of a Light Emitting Diodes Device for Therapeutic Use. J Med Syst. Mar 12;44(4):88. https://doi.org/10.1007/s10916-020-01557-y . PMID: 32166455
Elkins MR, Moseley AM (2015) Intention-to-treat analysis. J Physiother 61:165–167. https://doi.org/10.1016/j.jphys.2015.05.013
doi: 10.1016/j.jphys.2015.05.013
pubmed: 26096012
Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawrence Erlbaum, New Jersey
Lenhard W, Lenhard A (2016) Calculation of effect sizes, https://www.psychometrica.de/effect_size.html . Dettelbach, Germany: Psychometrica. Accessed 5 August 2019
Morris SB (2008) Estimating effect sizes from pretest-posttestcontrol group designs. Organ Res Methods 11(2):364–386. https://doi.org/10.1177/1094428106291059
doi: 10.1177/1094428106291059
Schindl A, Merwald H, Schindl L, Kaun C, Wojta J (2003) Direct stimulatory effect of low-intensity 670 nm laser irradiation on human endothelial cell proliferation. Br J Dermatol 148:334–336
doi: 10.1046/j.1365-2133.2003.05070.x
pubmed: 12588388
Frangež I, Nizič-Kos T, Frangež HB (2018) Phototherapy with LED Shows Promising Results in Healing Chronic Wounds in Diabetes Mellitus Patients: A Prospective Randomized Double-Blind Study. Photomed Laser Surg. Jul;36(7):377–382. https://doi.org/10.1089/pho.2017.4382 . Epub 2018 Apr 18. PMID: 29668397
Neteleki B, Abrahamse H, Houreld NN (2015) Conventional podiatric intervention and phototherapy in the treatment of diabetic ulcers. Semin Vasc Surg Sep-Dec 28(3–4):172–183
doi: 10.1053/j.semvascsurg.2016.02.001
Dungel P, Hartinger J, Chaudary S, Slezak P, Hofmann A, Hausner T, Strassl M, Wintner E, Redl H, Mittermayr R (2014) Low level light therapy by LED of different wavelength induces angiogenesis and improves ischemic wound healing. Lasers Surg Med. Dec;46(10):773 – 80. https://doi.org/10.1002/lsm.22299 . Epub 2014 Oct 31. PMID: 25363448
Rosa SSRF, Rosa MFF, Marques MP, Guimarães GA, Motta BC, Macedo YCL, Inazawa P, Dominguez A, Macedo FS, Lopes CAP, da Rocha AF (2019) Regeneration of Diabetic Foot Ulcers based on therapy with red LED light and a natural latex biomembrane. Ann Biomed Eng Apr 47(4):1153–1164 Epub 2019 Feb 1. PMID: 30710185
doi: 10.1007/s10439-019-02220-5
Nabuurs-Franssen MH, Houben AJ, Tooke JE, Schaper NC (2002) The effect of polyneuropathy on foot microcirculation in type II diabetes. Diabetologia Aug 45(8):1164–1171. https://doi.org/10.1007/s00125-002-0872-z Epub 2002 Jul 3. PMID: 12189447
doi: 10.1007/s00125-002-0872-z
Frangez I, Cankar K, Ban Frangez H, Smrke DM (2017) The effect of LED on blood microcirculation during chronic wound healing in diabetic and non-diabetic patients-a prospective, double-blind randomized study. Lasers Med Sci May 32(4):887–894. https://doi.org/10.1007/s10103-017-2189-7 Epub 2017 Mar 25. PMID: 28342007
doi: 10.1007/s10103-017-2189-7
Samoilova KA, Zhevago NA, Petrishchev NN, Zimin AA (2008) Role of nitric oxide in the visible light-induced rapid increase of human skin microcirculation at the local and systemic levels: II. Healthy volunteers. Photomed Laser Surg 26:443–449
doi: 10.1089/pho.2007.2205
pubmed: 18922087
Salvi M, Rimini D, Molinari F, Bestente G, Bruno A (2017) Effect of low-level light therapy on diabetic foot ulcers: a near-infrared spectroscopy study. J Biomed Opt 22:38001
doi: 10.1117/1.JBO.22.3.038001
pubmed: 28265648
Wagner VP, Curra M, Webber LP, Nor C, Matte U, Meurer L et al (2016) Photobiomodulation regulates cytokine release and new blood vessel formation during oral wound healing in rats. Lasers Med Sci 31:665–671
doi: 10.1007/s10103-016-1904-0
pubmed: 26868031
Robinson CC, Klahr PDS, Stein C, Falavigna M, Sbruzzi G, Plentz RDM (2017) Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials. Braz J Phys Ther Jul-Aug 21(4):233–243 Epub 2017 May 20
doi: 10.1016/j.bjpt.2017.05.008