Good morning Allo,
Spidey has already commented on your question and I defer to his expertise.
When I read the two versions side by side I noticed a few things. The use of language seems more descriptive with reference to some of the inclusion and exclusion criteria in the new version.
There have also been changes made to the exclusion criteria that may allow patients that may have previously been excluded to now be included? Please see below examples with my added comment.
"Exclusion Criteria
4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks [Comment: changed from 1 months to 2 weeks] prior to screening.
6. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks [Comment: changed from 1 month to 2 weeks] prior to screening.
15. Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2 [Comment: figures have been added, but I do not know what they mean, could it make it less restrictive as a criteria?].
16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase [Comment: it suggests that if anyone falls into the previous version's category they can now participate if in a long-term follow-up phase in relation to this specific point]."
Another observation is that a further exclusion criteria has been added. Previously there were 22 exclusion criteria and now there are 23.
This is the newly added exclusion criteria.
"17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor."
HappyBee
