Alright, let's have a look at some of your points:
Nowhere in these 'trials' are references to:
- Vascular surgery to promote increased blood flow and increased nerve response
- Surgical intervention in the wound (oversewing)
Why would there by references to surgery? That is not the standard of care for diabetic wounds. It is not realistic for the vast majority of diabetic wound sufferers to be treated with surgery. If it was, our hospitals would not be able to cope with any other conditions (and they're already at breaking point as-is).
Nowhere in these 'trials' are references to:
- Management of diabetes and improved control
- Management at home Vs Management in a clinical setting
This is what the control arm is for. Both those who receive the CYPatch and those that receive the standard patch receive the exact same treatment and care from medical professionals, with the patch initially applied at a clinic then mainly home visits thereafter. Notably, those who received the CYPatch have a nearly 90% reduction in wound surface area, compared to ~50% in the control arm.
Nowhere in these 'trials' are references to:- Follow up to confirm any successful improvements to vascular flow or diabetic control continues.
May I ask, have you read the Clinical Trial Study Plan? Because that is most certainly addressed, with "Incidence of changes from baseline in
haematology, biochemistry, and urinalysis parameters" a PRIMARY OUTCOME MEASURE.
(20min delay)