Thank you abjhu for your response. I do have the journal article to which you refer (abstract appended for others) in which 35.6% of patients with VG plus standard treatment had wound close at 12 weeks. I am well familiar with the chronic wound market and the costs DFUs impose on the health systems. But I am unable to find any economic studies for VG and of most importance, nor any controlled studies. I have raised this point before. We all believe that VG will be a good product and solution but until there are of controlled studies evidencing performance in a direct comparison against an accepted control (eg pressure alone) I do not believe it will be adopted by clinicians or obtainment of reimbursement. A small single arm non-controlled study as have been presented is not equivalent to a P2 FDA study and a full controlled study would be required by the FDA for US clearance. I do not understand why the company has not conducted such controlled trials as it may be that even a small sample of perhaps 50 (25 in each arm of trial) would indicate efficacy. But it may a strategy that VG get allowed CE marking and obtain sufficient sales in the EU that a large partner will pay for FDA studies.
