Funding for this research was provided by:
Conselho Nacional de Desenvolvimento Científico e Tecnológico (304124/2018-4, 407252/2018-5)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Financial Code 001)
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)
Text and Data Mining valid from 2020-02-13
Received: 18 January 2020
Accepted: 28 January 2020
First Online: 13 February 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. The trial was registered at ClinicalTrials.gov (a service of the US National Institutes of Health) with identifier NCT04008745 (2 July 2019) under the brief title “ Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People with Diabetic Neuropathy (FOCA-II)”<i>.</i> The main researcher will explain to each eligible participant every step of the assessment and follow-up, the possible risks, and the fact that no compensations or benefits are to be expected. When agreeing to participate, 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 use their data in the study; if they do not agree, 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 notified by submission of 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<u>.</u>
: Not applicable.
: The authors declare that they have no competing interests.