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Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods\/design<\/jats:title><jats:p>Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12\u2009weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12\u2009weeks, and follow-up at 24\u2009weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot\u2013ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>ClinicalTrials.gov,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04011267\">NCT04011267<\/jats:ext-link>. Registered on 8 July 2019.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-019-4017-9","type":"journal-article","created":{"date-parts":[[2020,1,13]],"date-time":"2020-01-13T14:02:49Z","timestamp":1578924169000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I"],"prefix":"10.1186","volume":"21","author":[{"given":"J. S. S. P.","family":"Ferreira","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. H.","family":"Cruvinel Junior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. 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It was registered at ClinicalTrials.gov (a service of the US National Institutes of Health) identifier NCT04011267 (on 8 July 2019) under the name \u201cEffect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People with Diabetic Neuropathy (FOCA-I)\u201d<i>.<\/i> The main researcher will explain to each eligible participant every step of the assessment and follow-up, possible risks and that no compensations or benefits are to be expected. When agreeing on participating, participants will be asked for written informed consent, according to the standard forms.On the consent form, participants will be asked if they agree to the use of their data in the study; if not agreed, they can choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the university taking part in the research or from regulatory authorities, where relevant.Any changes made to the protocol will be amended and communicated via a report sent to the sponsor and funder. The ethics committee will also be communicated by submitting a form via the national website of the research ethics committee,. Changes will also be included in the clinical trial register ().This trial does not involve collecting biological specimens for storage.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"73"}}