The FREEDOM trial: Is it sui generis?

Of course not all diabetic foot ulcers are ischemic and many can achieve healing with skillful foot care by a diabetic podiatrist. My point is this. Three out of three vessel disease is as sign of aggressive arteriosclerosis and durable revascularization occurred in the cardiac setting only with bypass surgery. On average, each patient who underwent angioplasty needed three or four more additional interventions. This need for repeat intervention occurs all too commonly in the neuro-ischemic diabetic foot as well. I lack the data to support the policy of bypass first but by a similar token there is no evidence to recommend "angioplasty first."

Isn’t is about time that we, too, devise flexible and appropriate treatment paradigms to revascularize diabetic feet at risk and heal them in the shortest possible time? It is probably too much to hope for a trial as conclusive as the FREEDOM trial but we need to organize trials or a registry for ourselves before the tsunami of diabetic patients engulfs us.

Thirdly, I was unable to understand how so many patients were eligible for inclusion and so few were trial-eligible: 32,966 patients were considered possibly eligible by virtue of receiving a coronary arteriogram for angina pectoris/signs of myocardial ischemia; only 3,309 met the criteria for randomization. I wish that the trialist had provided more information on why the other 29,657 were excluded. What happened to those patients during the 7 years required to complete this study? Likewise, of the 3,309 patients eligible for randomization, 1,409 refused randomization; what happened to them? It was quite an undertaking to screen nearly 33,000 patients and end up with 1,900 – less than 6% trial-eligible patients that were randomized. That percentage is less than the BASIL trial. Having said all of that, congratulations to the investigators on their study and for getting someone to pay for it. The money was well spent.

Dr. Andros is the Medical Editor of Vascular Specialist.