There does seem to be a bit of movement at the station, finally!...

There does seem to be a bit of movement at the station, finally!

Here is something rather intriguing to try to make sense of:

FTT subjects are Margolis 1 types: either their ulcer has existed for longer than 6 months or it is larger than 5 square cms.

Let's assume half the subjects belong to the “had ulcer for longer than 6 months”.

All subjects are put onto FTT's version of standard care bandaging for two weeks and any subject whose ulcer shrank more than 30% in those two weeks got kicked out of contention because they responded too quickly to standard care.

So the subjects that made the cut were non-vigorous healers in response to being in the study and receiving the study's version of standard care.

Then, four weeks after treatment commenced, the total group of subjects , placebo and treatment groups, had shown a 50% reduction in ulcer size.

Why would someone, who belonged to the group that had had an ulcer for more than 6 months, and hadn’t shown rapid response during the two-week standard-care only phase, suddenly have their ulcer shrink 50% in four weeks?

Powerful placebo effect? A technique that errs on the side of generosity for measuring shrinking ulcers? A delayed kick-in effect from having compression bandaging applied conscientiously over 6weeks?

...Or perhaps a genuine treatment effect?

I wonder if any other VLU studies have shown a 50% ulcer size reduction 4 weeks after treatment in their combined treatment/placebo group, especially if they eliminating fast responders before starting the trial?