Funding for this research was provided by:
Conselho Nacional de Desenvolvimento Científico e Tecnológico (304124/2018-4, 407252/2018-5)
Fundação de Amparo à Pesquisa do Estado de São Paulo (2019/02522-0, 2017/17848-3, 2017/15449-4, 2019/02624-8, 2019/06405-9)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Financial Code 001)
Text and Data Mining valid from 2020-01-13
Received: 13 October 2019
Accepted: 19 December 2019
First Online: 13 January 2020
Ethics approval and consent to participate
: This trial was approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE: 90331718.4.0000.0065), according to the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. It was registered at ClinicalTrials.gov (a service of the US National Institutes of Health) identifier NCT04011267 (on 8 July 2019) under the name “Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People with Diabetic Neuropathy (FOCA-I)”<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, ExternalRef removed. Changes will also be included in the clinical trial register (ExternalRef removed).This trial does not involve collecting biological specimens for storage.
: Not applicable.
: The authors declare that they have no competing interests.