Abstract
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.
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Acknowledgments
This research was supported by the Ministry of Health of Brazil (CNPq). Funding was provided by Ministry of Health Brazil (Grant No. TC 128 e TC 129), Coordenação de Aperfeicoamento de Pessoal de Nível Superior (scholarship), Conselho Nacional de Desenvolvimento Científico e Tecnológico (BR) (PQ), Conselho Nacional de Desenvolvimento Científico e Tecnológico (DT - Level 2).
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The following authors have intellectual property claims related to the work: S. S. R. F. Rosa, M. F. F. Rosa, and A. F. da Rocha.
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Rosa, S.S.R.F., Rosa, M.F.F., Marques, M.P. et al. Regeneration of Diabetic Foot Ulcers Based on Therapy with Red LED Light and a Natural Latex Biomembrane. Ann Biomed Eng 47, 1153–1164 (2019). https://doi.org/10.1007/s10439-019-02220-5
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DOI: https://doi.org/10.1007/s10439-019-02220-5