double blinded studies

Someone recently made some comments in relation to double blind tests so I thought I would check with TIS and have just received the following response from Steve Mercer:-

" A response to the forum comments you have quoted needs some background information on wound care trials, approval requirements and further explanation of the EU venous ulcer clinical trial of VitroGro® ECM.
The clinical trial requirements for CE approval of topical wound treatments requires only a single study comparing results to the widely published results that are obtained with current state of the art treatment from expert centres. These show consistently that with state of the art treatment, up to 50% of venous ulcers will not be healed after 20 weeks of care,.
The VitroGro® ECM trial in some ways exceeded the minimum EU requirements but was not a randomised control trial and was not double blinded. In the VitroGro® ECM study, 82% of patients had partial or complete healing after only 12 weeks treatment despite having had no response to expert care for an average of 3 years.
While it was not a control study, was a type of internal control in the CE VitroGro® ECM clinical trial, given that these patients were already being treated in expert wound clinics and the only change to their care was the application of VitroGro® ECM to the wound surface at routine dressing changes.
As far as I am aware, no currently approved wound care treatments have been through a double blinded prospective randomised control trial. Therefore, no existing venous ulcer treatments meet this standard of scientific proof.
At the same time, VItroGro® ECM does have more than a decade of peer reviewed published science behind it which as far as I know is unique.
The US FDA does now like to see results from a prospective randomised control trial for approval of topical wound treatments but does not require these studies to be double blinded. We are so confident of the science behind VitroGro® ECM and its principles of operation that we have chosen to do our venous and diabetic ulcer FDA trials as double blinded studies.
At the moment there is a significant global problem healing chronic ulcers with currently available treatments. No current treatments for these have been subject to double blinded prospective randomised control trials and very few have been subject to even non-blinded prospective randomised trials. The main reasons that wound care clinicians are so excited about being able to use VitroGro® ECM are that:
- it produces strong clinical results even in patients who have not responded to expert care for years
- there are strong and unexpected results in reduction or complete eradication of wound pain
- in all clinical trials to date there has not been a single adverse event related to VitroGro®

In other words, wound care clinicians and their patients have potentially much to gain and nothing to lose in using VitroGro® ECM."

A very positive response IMHO!

Regards......................