Ann: Proposed issue of securities - CYP, page-10

You:
"old standard" , "good standard" & "standard enough"

Me:
I don't think I follow, or perhaps I do but am of a completely different view?

I believe what you consider the "old standard" is merely not having "Study ulcer requires daily dressing changes" listed in the exclusion criteria. But who is to say if the first 6 patients did in fact receive a daily dressing change?
And looking at the original trial protocol, it actually said from the beginning "The dressings will be changed every 3 or 4 days." 3 or 4 days, not daily.
Where did you see/read that the first 6 patients received daily dressing changes?

Looking at the "International Best Practice

Guidelines: Wound Management

in Diabetic Foot Ulcers.

Wounds International,

2013. Available from: www.woundsinternational.com" it actually says:
"For infected or highly exuding wounds, a healthcare professional should inspect the wound and change the dressing daily, and then every two or three days once the infection is stable."
https://woundsinternational.com/best-practice-statements/best-practice-guidelines-wound-management-diabetic-foot-ulcers/

Infected wound = daily
Point 3. of the exclusion criteria of the P1 trial however has not been changed at any point and has always said, "Active infection in the study ulcer."

Question: Is the additional exclusion criteria of requiring daily dressing changes an actual change since active infections that would require daily changes have been excluded all along?

Therefore, isn't the old standard the same as the new standard and in line with the good standard as practised by the specialists in this field?