Thanks Werble for listing it clearly like that. So at what point...

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timkiely

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19/09/18

09:58

Post #: 35689802
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Originally posted by Werble ↑

Knew I’d seen it somewhere. The below is from the clinical trials website.. so outcomes listed with a timeframe of 12 weeks should be the ones that might be expected in November. Ones listed as up to 24 weeks (quality of life etc) will only be after the 12 week follow up (so presumably in feb some time as last follow up visit won’t be until mid jan)

Primary Outcome Measures :

The percentage reduction in the study ulcer area in each treatment group over the 12‑week Treatment Phase. [ Time Frame: 12-weeks ]
Patient's ulcers healing rate

Secondary Outcome Measures :

The proportion of patients with complete study ulcer closure within the 12‑week Treatment Phase [ Time Frame: 12-weeks ]
How many patient's ulcers healed?

Time to complete study ulcer closure within the 12-week Treatment Phase [ Time Frame: 12-weeks ]
Time to Ulcer Healing

Time to first instance of no study ulcer pain (i.e., pain score less than 5 mm on Visual Analog Scale [VAS]) within the 12‑week Treatment Phase [ Time Frame: 12-weeks ]
Measure of pain reduction to no pain

Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12‑week Treatment Phase [ Time Frame: 12-weeks ]
Measure of meaningful pain reduction

Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L [ Time Frame: Up to 24-weeks ]
Quality of life

Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W [ Time Frame: Up to 24-weeks ]
Quality of life - specific to chronic wounds

Other Outcome Measures:

The incidence of adverse events (AEs), including overall AEs, AEs related to the IP and study-ulcer-associated AEs. [ Time Frame: Up to 24-weeks ]
Safety

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Thanks Werble for listing it clearly like that.
So at what point can the company start delivering solid outcome information on the trial?
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