So here are the elephants in the room.
Increased vascular flow. Improved diabetes control - stable and reduced blood sugars. Poor Nerve sensation from neuropathy.
Nowhere in this bump is a reference to the defining factor that decides on success or failure. Increased blood flow.
Diabetic ulcers are 100% caused by narrowing of the blood vessels to the extremities caused by sedimentary deposits from high blood sugar and poor pain response due to nerve damage in the foot that prevents the normal response to damage - pain (therefore a warning of damage).
Nowhere in these 'trials' are references to:
Vascular surgery to promote increased blood flow and increased nerve response
Management of diabetes and improved control
Surgical intervention in the wound (oversewing)
Management at home Vs Management in a clinical setting
Follow up to confirm any successful improvements to vascular flow or diabetic control continues.
This has to be the most dreadfully vague trial I have ever seen - Almost willfully deceptive in fact.
And completely useless as a trial for this drug - or anything at all really.
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