Concerning the ethics issues: do you need approval for your ethics at the proposal stage, or is it sufficient to describe how you will deal with the ethical concerns?

It is sufficient to describe how you are planning to deal with ethical concerns and what the status of your ethical approval process is. To emphasize the likeliness and to increase the credibility that the ethical approval will be granted for this trial, it is helpful to mention your experience with any similar Clinical Trials (e.g. on national level) and explaining that you received ethical approval for those. Footwear