SCIENCE, PRACTICE AND EDUCATION DOI: 10.35279/jowm202107.07 The HERMES Study – blue ligHt photobiomodulation thErapy on neuRoischeMic patiEntS – Experimental Design and Study Protocol Alberto Piaggesi MD 1 , Alessia Scatena MD 2 , Sara Sandroni RN 3 , Stefano Gasperini 4 1 Diabetic Foot Section, Department of Medicine – University Hospital of Pisa, Italy 2 Diabetology Unit – S. Donato Hospital, Arezzo, Italy 3 Skin Lesion Network Hospital, Home Care – South East Tuscany Health Service, Arezzo, Italy 4 Medical Advisor – Pisa, Italy Correspondence: alberto.piaggesi@med.unipi.it · Conflict of interests: None Keywords: Diabetic foot, ischemia, blue light, photo-biomodulation, therapy ABSTRACT Aims To evaluate the safety and effectiveness of photo- biomodulation 1 therapy in addition to the standard of care (SoC) for managing diabetic foot ulceration (DFU), we designed a prospective randomised dou- ble-blind trial for neuro-ischemic patients (HERMES study), whose design and study protocol we describe in this paper. Patients and methods All patients with a chronic neuro-ischemic DFU wider than 1 cm 2 attending the S. Donato Hospital DF Clinic in Arezzo, Italy (I), will be screened for enrol- ment. After two weeks, while patients are treated with SoC, those whose lesions have not decreased by 50% or more in size will be randomised into two groups: the control group will be managed with SoC, while the study group will be treated with photobiomodulation + SoC twice weekly for 20 weeks, or until healing. Both groups will be managed in the community by visiting nurses. The outcomes [healing rates at 24 weeks (primary endpoint), healing times, speed of area reduction, pain, quality of life, adverse events] will be blinded to the treatment. Results As a pilot study, we cannot anticipate results, but we expect a positive difference of at least 15% in the study group’s primary outcomes, compared to controls, with no worsened safety profile. Conclusions and implications for clinical practice The interest of the HERMES study, beyond the findings related to the efficacy and safety of pho- tobiomodulation, lies in the characteristics of this low-cost, no-waste technology and its integration in specialist and community-based care. Background The complications of diabetes mellitus (DM) in the lower limbs, generically known as ‘diabetic foot’ (DF), affect one in three patients with DM at least once in their life and represent the most prevalent cause of lower extremity amputation (LEA) in the world, such that it is estimated that a limb is lost every 20 seconds because of DF. 1,2 JOURNAL OF WOUND MANAGEMENT OFFICIAL JOURNAL OF THE EUROPEAN WOUND MANAGEMENT ASSOCIATION 55
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