Advanced Therapies For The Diabetic Foot: Are We Getting Our Money’s Worth?

In a recent issue of Diabetes Care, Kahn and Anderson examine the issue of diabetes care as a model for healthcare reform.1 The authors point out that the prevention of diabetes and the prevention of complications associated with diabetes are seldom cost-saving. This is contrary to many arguments that suggest preventive care is ultimately cost-effective and reduces expenses associated with the management of diabetes.

While no one would argue that the prevention of diabetic foot complications is certainly “cost effective” with regard to human suffering, such as the prevention of amputation in a patient with diabetes, the question of financial realities surrounding the prevention of amputation is a different matter altogether.

In regard to the issue of comparative effectiveness of various interventions, I would like to specifically address an analysis of technology associated with the evaluation and management of diabetic foot pathology.

Podiatric CME meetings are heavily dependent upon corporate sponsorship. It is not a coincidence that corporations listed as platinum, gold or silver sponsors at these meetings provide speakers who endorse various products, many of which are quite expensive.

In some instances, entire programs appear to be industry supported and the lecture content of these programs seem to be substantially or entirely controlled by corporate sponsorship. As a result, various products are promoted and endorsed, and they come to be accepted by those in attendance as the “standard of care.”

As noted by Kahn and Anderson, some technology “has gained widespread adoption without much evidence that it is cost-effective for all persons with diabetes.” I would like to explore this concept with readers this month.

Raising Questions About The Cost And Long-Term Benefits Of Advanced Modalities

Examples of technology, which have been accepted, would include the use of bioengineered products for ulcer management or the utilization of external fixation for reconstruction of Charcot's joint disease. We frequently do not hear much regarding alternative methods of treatment for ulcers because there is no corporate sponsorship for non-weightbearing and casting in the management of Charcot's joint disease. Instead, corporations are more than happy to provide speakers to endorse the utilization of large external fixation, orthobiologic materials, bone stimulators and other technologies that physicians can employ for the treatment of Charcot's joint disease.

The question, however, is whether such technologies provide any clear advantage to the treatment of these problems over alternative methods that do not involve the application of expensive advanced technologies. Traditional management may take longer to achieve a result but is the expedited effect of advanced technology worth the cost?

Many of us who treat patients with significant pathology, such as Charcot's joint disease, have patients who have refused surgical intervention. I would argue that the outcome in such patients has been essentially no different than those who have undergone surgical intervention.

Granted, surgical intervention offers the opportunity to reconstruct anatomy and provide the patient with a more normal looking foot than the patient who declines surgical intervention. However, it is also true that surgical intervention in the patient with Charcot's joint disease is associated with a variety of possible surgical complications. This is not to suggest that advanced technology is not useful in the management of Charcot's joint disease. However, there are no clear studies that indicate a distinct long-term advantage to the treatment of Charcot's joint disease with a variety of expensive technologies in comparison to more traditional, minimally invasive, limited surgical or non-operative treatment of the same problem.

The examination of advanced technology in the treatment of the diabetic foot must also include bioengineered products. All of these products are quite expensive and, in my opinion, are frequently utilized at the urging of corporate representatives rather than patient need.

Somehow, over the years, I had been able to heal the majority of patients with diabetic wounds in my practice without the need for hyperbaric oxygen or advanced wound care products. However, the corporations producing such products as growth factors and various skin equivalents dominate the educational sessions at meetings where wound care is discussed. As is the case with Charcot's joint disease, the alternative viewpoint is not discussed because there is simply no potential profit to any corporation in discussing more traditional approaches to wound care.

Somehow, I have had great success in the healing of venous ulcerations by utilizing in-office debridement, appropriate topical agents and old-time Unna’s boots. Of course, I will utilize advanced wound technologies when necessary. However, I do not believe that the majority of patients that I have cared for required such technologies.

My complaint is we have started to utilize expensive technologies without any firm basis of significant long-term benefit that would justify the cost. I would not argue that the use of certain bioengineered products might expedite the resolution of ulcer but at what cost? I would not argue that the utilization of external fixation might speed the resolution of a Charcot's joint deformity or provide a more normal anatomical presentation of the foot following such surgical intervention but at what cost? Where is the long-term data to suggest that these patients are ultimately better served than those patients who were provided more traditional conservative management?

Are We Getting The Education We Need At These Conferences?

We are now facing healthcare reform. The frequency of diabetes is increasing dramatically in United States and throughout the world. Podiatrists are increasingly providing preventative as well as interventional care for patients who have been diagnosed with diabetes.

The late James Ganley, DPM, once referred to the “technological imperative,” examining the proposition that newer is always better.

Given the strong dependence upon corporate sponsorship, the content of many of these meetings is severely limited and provides the practitioner with only those educational objectives that can be encompassed within corporate sponsorship. When a speaker receives support from a corporation, he or she may be ostensibly “neutral, fair and objective.” However, he or she is not likely to continue as a speaker for a corporation unless a certain message is delivered to those attending that meeting.

The next time you receive a brochure for a “scientific program,” look at the contents and correlate this with the listed corporate sponsors. You then begin to understand why certain advanced technologies have become accepted without any firm evidence of long-term benefit.

Are Unrestricted Educational Grants Truly ‘Unrestricted’?

I am not certain how to change our current corporate influence on CME provision. I constantly hear the argument that without such sponsorship, it would be financially difficult to provide CME programs. However, with such sponsorship, post-graduate education in our profession has become limited to just a few topics such as wound care, bone growth stimulators, external fixation, fixation devices and various pharmaceuticals.

At times, many of these CME programs remind me of the movie Groundhog Day, as it seems we are seeing the same topics over and over and over. There are exceptions such as the annual scientific meeting of the American College Of Foot and Ankle Surgeons (ACFAS). To their credit, the ACFAS provides a lecture program with little corporate sponsorship.

The solution is to make an unrestricted educational grant truly unrestricted. Somehow, when I look at programs “provided by an unrestricted educational grant from … ,” it appears to me the content of these programs is anything but “unrestricted.”

Perhaps we can eventually have forthright discussions regarding the proper place for advanced technology in the treatment of the diabetic foot and determine the true need for, and effectiveness of, such technologies. Until this happens, you will see the same speakers giving the same lectures and discussions of the same limited topics.

I welcome responses to this commentary.

Reference
1. Kahn R, Anderson JE. Improving diabetes care: the model for health care reform. Diabetes Care 2009 Jun;32(6):1115-8.