Procedural Mistakes or lack of public information's in reference to the EU andFDA Trial

To all of you.
I have spoken to an active internatIonal biotech company that has dealt in the wound care for many many years.
He has referred to very interesting and critical points on how FTT has led the trials and led to a high placebo response, determining as a consequence a poor IGF-1 factor FTT medical device result.

To run a wound clinical trial against a placebo is a very risky business and the comparIson of what Is consIdered a "standard of care" change substantIally among countrIes.

The maIn poInt that the types of dressIngs used in "standard of care" change by country, by the cost and off course their effectIveness.

There are costly supportIve medIcatIons in standard of care that works quite good and provIde good patIent responses, but on the other sIde thIs good response in wound closure and rate of healIng in standard of care has a hIgher cost and as a consequence a bad effect on the State Health Budget or on the insurance provIder that covers the patIent.
So If in the US clInIcal trIal, the medIcatIon used In the standard of care were In the hIgh end value, clearly the placebo response is good.

But what about the health economIc of the treatment?
There Is no reference anywhere about the HEALTH ECONOMICS of the standard care of treatment used agaInst FTT medIcal devIce. The same applIes even for the fIrst European UnIon clInIcal trial where there is no dIrect reference to the cost of treatment of standard of care agsInst the VItrocard.

This is a major conceptual faIlure that makes the trIal run In a complex and hazardous terrItory. The absence of the health economIc of the standard of care dressings used In the placebo group agaInst the FTT medIcal devIce compromIse the trIal.
ThInk now.
Suppose that in the US trIal has been used an expensIve standard of care dressIng and procedure that has a cost of $2,000-$3,000 per treatment day. BeIng In the hIgh end sIde of tratmemt value, the patIent wIll be led to have a good wound response. Now suppose the FTT appllicatIon costs wIth Its semplIcIty in total $ 1,500.
If the two wound closure and rate of healIng In the end almost match or the FTT devIce performs just a bIt but not much better, would you consIder a better value the standard of care used(cost $2-3,000) or the cheaper FTT medIcal devIce?

In case of the US the basIc of wound standard of care cure changes by States and Health Budget. Of course a patIent wIth no health Insurance and lIvIng In Arkansas does not receIve the same standard of care of an Insured patIent in Boston or New York.

ThIs Issue Is even more vIsIble in Europe, where due to straIned and burdened NatIonal Health Budgets, the standard of care changes dIfferently from NatIon to NatIon. It Is posdIble that If you go now to a clInIc in Greece, you get just the basIc wound cleanIng, some BetadIne, and nothIng else besIde the bandage.

So exIstIng many types of "standard of care" in the world, a placebo control testIng Is altered based on where you decIde to do the trIal, the cost of standard of care, the dressIngs used (hIgh end, generIc or very basIc), the Insurance coverage of the patIent, the country state health budget (Greece is not Germany), and the clInIcs and hygIene where you get the medIcal treatments (there are many types of generIc drugs avaIlable in the standard of care).

In the end, withIn the generIc standard, the clInIc or the State Health Budget are run on the cheaper solutIon or in case of State Health Budget, the most Inefficient cheaper solutIon.

LogIcally, if in a trial you use the hIgh end value of standard of care, you get as a response a hIgh placebo healIng rate, but the treatment by itself Is much more expensIve.

If no health economIc Is done in thIs case is better to test the FTT medIcal devIce agaInst a no standard of care scenarIo. Just salIne water and bandage, but thIs wIll cause the patIent to be in danger beIng not treated.

Another Important poInt that I do not see raIsed In the trIal is the progress in the "qualIty" of the wound cIcatrIzatIon and how much sudatIon there Is on the wound durIng the trIal. But agaIn the main poInt of such a trIal is In the cost economics of the no care scenarIo and care scenarIo and the cost economIcs of the medIcatIons used in standard of care agaInst the costs of a FTT medIcal devIce.

If you do not have this data comparIson, the trIal is led to an extremely hIgh percentage of failure. ThIs Is what has happened In our case.

You cannot compare a Rolls Royce to a SuzukI. Moreover the maintenance and standard of care of the car changes by country to country.