Biomedical Engineering Program, Faculty of Gama, Brasília, DF, 72.444-240, Brazil.
, Colina Bloco H Apt.408, Campus Universitário Darcy Ribeiro, Asa Norte, Brasília, DF, CEP: 70904-108, Brazil.
Ann Biomed Eng. 2019 Apr;47(4):1153-1164. doi: 10.1007/s10439-019-02220-5. Epub 2019 Feb 1.
This study analyzes the effects of the Rapha system, which employs red light therapy (RLT) and a natural latex biomembrane in the healing of neuropathic ulcers associated with the diabetic foot. We conducted a randomized, controlled, blinded clinical trial with 15 participants that were divided into three groups (GI, GII and GIII): (i) Rapha system application by the participant and a health professional at home, with clinical status evaluation every 2 weeks at the hospital (GI); (ii) standard protocol used in Brazil, performed by a health professional at the hospital (GII; control); and (iii) the Rapha system applied by the participant at home and clinical status evaluation every 2 weeks at the hospital (GIII). We used image processing techniques on photographic recordings of the lesions, and several statistical tests were used to analyze the data, allowing for the comparison of the average results for all groups. The average healing rates of GI, GII, and GIII were 77.0, 51.4, and 80%, respectively. The granulation tissue evaluation indicated a higher efficacy in the tissue repair of lesions treated with the Rapha system. In conclusion, the Rapha system proved to be an effective healing system, even when self-applied at the patient's home.
本研究分析了 Rapha 系统在治疗糖尿病足相关神经溃疡中的作用,该系统采用红光疗法(RLT)和天然乳胶生物膜。我们进行了一项随机、对照、盲法临床试验,共有 15 名参与者分为三组(GI、GII 和 GIII):(i)参与者和家庭健康专业人员在家中使用 Rapha 系统,每两周在医院进行临床状态评估(GI);(ii)巴西使用的标准方案,由医院的健康专业人员进行(GII;对照组);和(iii)参与者在家中使用 Rapha 系统,每两周在医院进行临床状态评估(GIII)。我们对病变的照片记录使用图像处理技术,并且使用了几种统计测试来分析数据,从而可以比较所有组的平均结果。GI、GII 和 GIII 的平均愈合率分别为 77.0%、51.4%和 80%。肉芽组织评估表明,Rapha 系统治疗的病变组织修复效果更高。总之,即使在患者家中自行应用,Rapha 系统也被证明是一种有效的愈合系统。