Don’t restrict your thinking about efficacy re DFUs etc. to what...

Don’t restrict your thinking about efficacy re DFUs etc. to what is being packaged as SynPath. The use of the BTM matrix and it’s derivatives has been used, and is being used, on these chronic wounds beyond the 10 patient study you refer to. It works.

As to the reimbursement trial, read again more carefully the italicised text you quoted. The problem is not that it doesn’t work but rather its working risks being compromised by trial participants’ actions. Hence the importance of protocols - the clarity and effectiveness of those protocols in maximising the utility of the treatment. I suspect that the training of podiatrists in the use of SynPath is crucial here and protocols around that issue is the focus of the second look at study design: controlling for how the clinician has used the device.