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The VenUS3 healing curve FTT run alongside the blinded data is a...

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ViperX1

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20/07/18

13:06

Post #: 34476033
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Originally posted by markf17 ↑

Patients in VF00102 study seem to be 'given the same process' as in VenUS111UK study but was there a difference between ulcer severity and time to heal between patients recruited for the two studies?

The recruitment criteria for the VenUS111 was - Patients were eligible to participate in the trial if they presented with a venous leg ulcer of >6 months’ duration or >5 cm2 and an ankle–brachial pressure index of ≥0.8.
Patients with hard to heal ulcers (Margolis 3) were excluded from VF00102 whereas patients with hard to heal ulcers may have been included in VenUS111. Placebo arm patients in current study may thus have faster and more complete healing than in earlier study. As viper points out if current placebo group healed 17.5% faster than previous study the primary VF00102 endpoint of more than 10 percentage points improvement may not be met.

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The VenUS3 healing curve FTT run alongside the blinded data is a subset of VenUS3 that they think best matches the recruitment criteria for the VF study.

I have no idea how they select the subset.

FTT Price at posting: 5.5¢ Sentiment: Buy Disclosure: Held
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