With just 6 patients - 3 being standard of care - I don't think its a coincidence that we aren't seeing claims of statistical significance or p values - I don't think enough data is in yet to draw statistical conclusions.
Where a surgeon cuts under antiseptic conditions along a line to remove the big toe is that really the same as when a wound occurs (presumably not during surgery and not under the same conditions of closely watching for infection etc) are the wounds actually truly comparable or has some confounding elements been introduced such that more than the diabetics natural capacity to heal or not is being measured? I don't know.
To me these results seem to preliminiary- I think David Hunter talking about Sculptor and comparing with other stem cell treatments (so not about DFU) used a phrase that some other research in OA was little better than an anecdote.
Maybe this DFU stuff - just six patients - half treated - half not - is also little better than an anecdote. We aren't seeing pictures for the other four even.
Polynovo has a DFU trial running as well. There is at least one other company in this space besides Polynovo. By the time DFU is done - standard of care may not be standard of care if any other promising treatments are available earlier - say the PNV trial gets up and is successful - or at the same time.
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