Landmark Studies with the Circulator Boot
We are grateful to Angiology for their permission to provide our readers with scans of some of the articles on the Circulator Boot™ printed in their journal. Some bound reprints are still available at Angiology for the interested reader.
Boot therapy has a long history that dates as far back as 1812. Over the last 190 years there have been continual improvements in the technology, but, as in the case of vascular reconstruction procedures, there have been few small or large controlled studies to justify the treatments. Such studies have been considered unethical by our vascular surgeons. Indeed, as the Helsinki guidelines for human research now advise against placebo-controlled trials, such trials may never be done again. Clinicians find it difficult to enlist patients unless they promise to make their best therapeutic efforts.
In the first report are found the results of Circulator Boot treatments in 1035 patients and 1514 legs representing 2177 episodes of leg problems. These patients were referred by over 126 physicians in our community. Others were referred by visiting nurses, other patients, friends and, on occasion, the Delaware Valley office of the American Diabetes Association. This report might be considered a prospective Medicare study for the following reasons: (a) Medicare paid for the treatments of most of the patients during the course of the period reported; (b)Baseline data was accumulated on presentation of the patients (both historical and new vascular data, photographs etc); (c) Letters to referring physicians summarizing previous treatments, tests, and the results of the Circulator Boot treatments were regularly generated; (e) In that Dr. Dillon and his clinic became the most prominent user of the medicare codes assigned to the treatment, formal record reviews of Dr. Dillon and the clinic were performed by Medicare (three site visits, three chart reviews and one Administrator Judge review); in all cases our care was deemed appropriate and successful. One might ask how many other studies on the diabetic foot have been so closely documented and observed. Medicare, of course, always had the option of requesting refunds of their payments. The referring physicians always had the option of recommending to their patients that they leave us for other treatment centers.
Our patients had largely already failed standard forms of therapy and, in this sense, were their own controls. Again, as Medicare only paid for treatment of the "bad leg", the other leg became a "control leg" and proved to fare worse than the presenting "bad leg" (P<0.001). Large "observational studies" have been shown to correlate well with "placebo-controlled clinical trials" (BMJ 1996;312:1215-1218; New Engl J Med, 2000 Jun 22;342(25):1878-86.; New Rngl J Med 2000 Jun22;342:1887-1892; NeuroRx 2004;1:341-347.). Patients less ill than those described in these pages might be reasonable subjects of a controlled clinical trial; their care is not urgent and many can be expected to get better with other conservative means. Such a study, however, would require large numbers of patients, multiple clinics and a large sum of money.
The author did his best to produce a 15 year prospective study. The reader is invited to study the methods section of this article and decide independently how in a clinical setting it might have been made a better study.
The second study provides the clinical details
and explanations about the treatments. This is largely a "How to"
paper. Our "Patient History" section broadens this material
Fifteen Years of Experience in Treating 2177 Episodes of Foot and Leg Lesions with the Circulator Boot (photographs of journal pages best viewed by cable or DSL)
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