光生物调节作为糖尿病足溃疡预防性治疗的效果：随机、对照、双盲临床试验方案
Effect of photobiomodulation as preventive treatment of diabetic foot ulcer: randomised, controlled, double-blind, clinical trial protocol.
作者信息
Lourenço Roselene, Perez Silvana Torres, Motta Lara Jansiski, Duran Cinthya Cosme Gutierrez, Padilha Alexandre Rocha Santos, Bussadori Sandra Kalil, Malavazzi Tainá Caroline Dos Santos, Horliana Anna Carolina Ratto Tempestini, Mesquita-Ferrari Raquel Agnelli, Fernandes Kristianne Porta Santos
机构信息
Biophotonics Medicine, Universidade Nove de Julho, Sao Paulo, Brazil.
Conjunto Hospitalar do Mandaqui, Sao Paulo, Brazil.
出版信息
BMJ Open. 2025 Jan 22;15(1):e094594. doi: 10.1136/bmjopen-2024-094594.
INTRODUCTION
The prevention of diabetic foot ulcer (DFU) involves the classification of risk, systemic care, regular examinations, foot care, therapeutic education and adjunct treatments. Photobiomodulation (PBM) has been successfully administered for the healing of DFU and its preventive effects have drawn the interest of researchers.
METHODS AND ANALYSIS
The purpose of the study is to assess the effect of PBM for the prevention of DFU through a randomised, controlled, double-blind, clinical trial. Individuals from 18 to 75 years of age of both sexes with type 2 diabetes mellitus (DM) at moderate to high risk of developing DFU will be randomly allocated to two groups of 32 participants each. The PBM group will wear a boot with 1344 light-emitting diodes (LEDs)-504 with a wavelength of 660 nm located on the sides of the boot (28.5 mW, 10 J per LED), 504 with a wavelength of 850 nm also on the sides of the boot (23 mW, 8 J per LED), 168 with a wavelength of 660 nm on the base of the boot (28.5 mW, 10 J per LED) and 168 with a wavelength of 850 nm also on the base of the boot (23 mW, 8 J per LED). The boot will be worn once a day for 6 min over 60 days and the participants will also receive therapeutic education. The control group will wear a non-therapeutic LED boot (sham) under the same conditions and will also receive therapeutic education. Assessments will be performed at the beginning of the study, after 30 days (clinical examination) and after 60 days (clinical examination, assessment of peripheral neuropathy (PN) and peripheral artery disease (PAD), blood and urine examinations and quality of life).
ETHICS AND DISSEMINATION
This protocol received approval from the Human Research Ethics Committee of Nove de Julho University and the Mandaqui Hospital Complex (certificate number: 66098522.0.3001.5511; final approval date: 22 June 2023). The findings will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
NCT06353568, ClinicalTrials.gov.
引言
糖尿病足溃疡（DFU）的预防包括风险分类、全身护理、定期检查、足部护理、治疗教育和辅助治疗。光生物调节（PBM）已成功用于DFU的愈合，其预防作用引起了研究人员的兴趣。
方法与分析
本研究的目的是通过一项随机、对照、双盲临床试验评估PBM预防DFU的效果。年龄在18至75岁之间、患有2型糖尿病（DM）且发生DFU风险为中度至高风险的男女个体将被随机分为两组，每组32名参与者。PBM组将穿戴一种靴子，靴子上有1344个发光二极管（LED）——靴子侧面有504个波长为660 nm的LED（28.5 mW，每个LED 10 J），靴子侧面还有504个波长为850 nm的LED（23 mW，每个LED 8 J），靴底有168个波长为660 nm的LED（28.5 mW，每个LED 10 J），靴底还有168个波长为850 nm的LED（23 mW，每个LED 8 J）。该靴子每天穿戴一次，每次6分钟，持续60天，参与者还将接受治疗教育。对照组将在相同条件下穿戴非治疗性LED靴子（假装置），也将接受治疗教育。评估将在研究开始时、30天后（临床检查）和60天后（临床检查、评估周围神经病变（PN）和外周动脉疾病（PAD）、血液和尿液检查以及生活质量）进行。
伦理与传播
本方案已获得新朱利奥大学人类研究伦理委员会和曼达基综合医院的批准（证书编号：66098522.0.3001.5511；最终批准日期：2023年6月22日）。研究结果将发表在同行评审期刊上。
试验注册号
NCT06353568，ClinicalTrials.gov。
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