Kenneth B. Rehm, DPM
Board Certified in:
• Podiatric Surgery
• Podiatric Medicine
• Prevention and Treatment of Diabetic Foot Wounds & Shoe Therapy
• Limb Preservation & Salvage
Medical Director: The Diabetic Foot & Wound Treatment Centers, Inc.
Medical Director and Administrator: Cardiovascular Diabetic and Limb Preservation Alliance (CDLA)
Ask any health care provider. The practice of medicine, and, indeed, the role of the doctor, has been transformed significantly (1). Time was, a patient would come in to the office and the doctor could take all the time required, order the tests needed and make the necessary referrals such that an optimum diagnosis and treatment plan could be formulated. The doctor was in charge, not the system. No formularies, no authorizations, no disputing who the patient can go to for what; no ambiguity on what is covered by insurance; and whatever the physician thought was in his patient’s best interest was implemented. No more. The doctor is now at the whim of his controllers (2). The patient is no longer getting the care, attention, or time spent with the doctor needed for optimal treatment, let alone, solid preventive care. And what is the result? Poor health care! Who suffers? The patient suffers! Those with foot problems related to their diabetes are certainly not excluded from this dismal state of affairs.
The obstacles, including the social challenges intertwined here as well, are so extensive and so complex that prevention seems to be the only way out! (3) Given these set of circumstances, the old guidelines for foot care in diabetes, dealing with just the feet, are passé. The attention on prevention needs to be more holistic. The feet are attached to the rest of the body and new guidelines have to reflect that in order to obtain unchecked prevention. This article makes an effort to put together all the many ingredients of the “prevention soup”, if only just to put it out there; and that it needs to be dealt with. Even though the goals are lofty and the mission is immense, to treat the subject with integrity, this treatise is delivered in two parts. The first deals with the challenges; and the second half discusses the solutions, culminating in updated guidelines. This is only the beginning of a long hard journey. Let’s start! Here is Part I.
WHAT IS PREVENTING PREVENTION?
Look around you. Everywhere you turn, people are unwittingly torturing their bodies and mind by doing and eating the worst perpetrators of ill health. At the average restaurant, ordering a portion of “mystery meat” with a side of fructose corn syrup and trans fat is not an unusual occurrence. At breakfast time at the same eatery, it is hard to miss the preponderance of patrons indulging in unhealthfully delicious pancakes or waffles smothered with butter and syrup next to the greasy sausage and fried eggs, all with a side order of white bread toast with all the nutrients and fiber bleached out of them.
Similarly, the desirable shelf space in any typical supermarket is dominated by imitation food, which contains an abundance of preservatives and unhealthy sugars. By the same token, it is not unusual to find students at a fast food or a convenience store, perhaps near a high school, “hanging out” drinking large sodas, bags of chips, and smoking cigarettes. (4)
Correspondingly, at the emergency room, private office or the community clinic, it is not uncommon to see patients with deep ulcerations, infections, gangrene, or Charcot deformity with uncontrolled diabetes, who do not take their medication, watch their diet or monitor their blood sugars; while at the same time refusing to wear appropriate footwear and show up for their appointments to see their healthcare providers.
One cannot overlook the primary care physician who just doesn’t have the time to delve as deep as need be into a patient’s history to uncover a masking truth, which may change the course of his patient’s care. How about the clinician who hears hoof beats but misses the zebras because he is just looking for horses? How about the podiatrist who is seeing the patient for nail care but misses a stage I ulceration of the heel?
In partial defense, however, most podiatric physicians and surgeons, and other health care providers involved in chronic illness are, understandably so, throwing up their hands in exasperation. They are like salmon swimming up stream; struggling with a host of discordant issues not the least of which is the corporate food structure, financial challenges of all parties involved and the frustrating abyss of patients’ non-compliance and non-adherence. How can they do their best for their patients when there are so many adverse, conflicting circumstances?
To offer a riposte to these fundamentally critical questions, let’s take a closer look at these clearly complicated issues.
Consider the average person who has limited health resources and knowledge. Let’s assume that this person would be intensely motivated to be healthy, follow all the rules meticulously and do whatever it takes to improve their well-being; striving to be thoroughly compliant, conscientious and diligent in forming health-forming habits.
It is interesting to note that at this time in the evolution of our healthcare model, even with this faultless example, it might very well be the healthcare system itself that stands in the patient’s way of obtaining good health.(5) What with the necessity of following the fastidious rules of insurance companies, the mound of protocols and formularies and the warped framework in which physicians must practice their disciplined, meticulous, supposed-to-be patient centered, often conflicting craft, the patient may not get optimum care or counseling. The blend of art and science in the practice of medicine has become skewed.
Considering also the present-day onset of opposing influences that appear to be incompatible with supporting a wholesome lifestyle, we need now to consider a new paradigm for prevention of disease, including diabetes mellitus and all of its complications, including diabetic foot disease.
WHAT EXACTLY DO WE WANT TO PREVENT?
First, to better understand precisely what it is that we want to prevent, that would ultimately lead to lower extremity amputation, let’s discuss and define diabetic foot disease.
The cornerstone of this devastating complication of diabetes is the onset of peripheral arterial disease and also peripheral neuropathy. Clinically, either complication can be predominant, with any of its many manifestations, or can exist as co-equals, but always intertwined.(Figure 1) Because neuropathy is, in part, a microvascular condition, structural damage to the microvasculature can ultimately lead to nerve dysfunction, which is central to the pathogenesis of peripheral nerve injury in diabetic neuropathy. Other factors that are also instrumental, depending on the type of diabetic neuropathy involved, include the following:
- • Metabolic factors, such as high blood glucose, long duration of diabetes, abnormal blood fat levels, and possibly low levels of insulin.
- • Autoimmune factors that cause inflammation in nerves
- • Mechanical injury to nerves, such as tarsal tunnel syndrome
- • Inherited traits that increase susceptibility to nerve disease
- • Lifestyle factors such as smoking, alcohol use and effects of recreational and prescription drug regimen.
The end result of these destructive influences could result in lower extremity amputation, deterrence of which is one of the principle goals in any diabetic prevention program. The typical course of these progressive states leads to amputation in the following ways. (Figure 2)
Sensory neuropathy can cause loss of sensation, which can trigger an amputation by not being able to feel the mechanical insult to the foot. This insult is invariably associated with three basic types of pressure: direct pounding, friction rubbing, and shearing tearing. These forces cause tissue damage, inflammation, callous formation, ulceration and ultimately infection. There is a fourth type of pressure, which is a permissive factor for amputation, and not necessarily associated with sensory neuropathy, which is the pressure of spreading infection.
Motor neuropathy is associated with weak, tight and imbalanced muscle groups, mallet and hammertoe formation and altered gait. This in turn can trigger pressure points and ulcerations by being a source of harmful contact of the foot with the floor and with the shoe. When loss of protective sensation co-exists, the foot continues to ulcerate to a deeper level, potentially eventually infecting the bone. Lower extremity amputations are caused by these destructive influences.
In autonomic neuropathy, dry, cracked, scaly skin can be a nidus for infection and can cause loss of limb in this way. (Figure 3)
Peripheral arterial disease in a person with diabetes poses a risk, most commonly in the following way. After an insult to the foot, usually an ulceration associated with loss of protective sensation or traumatic skin injury, lack of circulation to the affected area makes it difficult or even impossible to heal, allowing gangrene or infection to progress. If circulation is not restored via vascular surgery or interventional procedures, surgical intervention or antibiotic therapy is often unsuccessful and amputation becomes the only alternative to save a patient’s life.
Charcot foot deformity is often part of the clinical picture of diabetic foot disease. The term “neuropathic arthropathy” is used to describe the Charcot process because the central problem is that the weight bearing joints of the foot are pathologically affected by lack of appropriate nervous input. This can result in the bones of the feet fracturing or becoming “powder”, thereby allowing the foot to become misaligned. This process is associated with diabetic sensory, autonomic and motor neuropathy. As peripheral neuropathy progresses, the joints are not reactive to the forces put across them and movement of the various joints are distorted. The body does not adjust to these forces and positions; thereby acting as a permissive factor for microtrauma, microfractures as well as frank fractures. Repetitive trauma or microtrauma that exceeds the rate of healing may cause the clinical manifestations of Charcot foot such as dislocations, additional fractures and breakdown of the weight bearing joints. Motor neuropathy contributes to this collapse as the muscles lose the ability to support the foot properly. Autonomic neuropathy, nerve pathology of the autonomic nervous system, which controls regulation of blood vessels, and skin moisture, is contributory here as well. This disorder may result in increased blood flow to the lower extremity and therefore may contribute to the edema and osteoporosis that ensues as the Charcot process progresses. In addition, the skin is more susceptible to breakdown, given the effects of the autonomic neuropathy.
Prevention is always the best treatment when it comes to Charcot deformity. In a person with diabetic neuropathy, awareness of trauma to the foot, any temperature variations between right and left feet or changes in the appearance is absolutely necessary and key to stopping Charcot foot in its tracks before the destructive processes become too advanced. Weight bearing without specifically designated footwear is likely to make the condition worse; keeping in mind, however, that the gold standard for treatment is the total contact cast. This modality is the optimum mode of reducing pressure on the affected foot and represents the clinical application of the formula PRESSURE= FORCE/AREA.
PUTTING OUR CHALLENGES TO PREVENTION IN CONTEXT
Bearing in mind that our mutable health care system is in crisis, it is categorically incumbent upon all health care providers to be reformers and consider prevention in all its expressions. Current professional attitudes and public awareness regarding prevention of disease need to be postured somewhat differently than they were perhaps 10 years ago.
We are trying to fix a health care system with insurance related solutions, but the problems at hand suggest that the health care crisis is not necessarily an insurance problem, but more of a cultural, societal, psychological-social challenge.(5) To remedy this unpromising state of affairs, every person must be held accountable and assume a fair amount of responsibility for his own health status and be the captain of his own “health ship”. That is, it incumbent upon people to be an active and proactive participant in their healthiness instead of remaining passive and reactive.
It is, of course, understood that a certain segment of those suffering from disease will not be able to attain such lofty status; and health care providers and innovators must incorporate this fact into their attempts at preventing illness. Health care “providing” then must incorporate the rolls of mentor, coach, motivator, psychologist, teacher and of course, physician. This surely would require a team approach to be able to incorporate all these different roles such that a productive outcome, which would accomplish their healthcare goals, would be the result; and if effective, the team would surely be able to support this person in incorporating personal responsibility into their own health care. There is substantial evidence that the team approach is considered by experts to be the gold standard in the care of those afflicted with chronic diseases, such as diabetes mellitus. (6)
It is in this light that the ordinary guidelines(figure 4) for prevention of diabetic foot disease must be augmented; and by necessity include strategies for mental, psychological, social, educational and overall physical well-being, as well as incorporating the customary model for diabetic foot care. (7) The following discussion will therefore give the captain of the “health ship” a map in which to navigate through the stormy seas of prevention.
So far we have expounded on the need for prevention of diabetic foot disease and what it is that we need to prevent. When these problematic circumstances are given ample consideration, it becomes clear that prevention is the best treatment. (Figure 5) But how do we prevent such a complex multi-faceted disease state?
To start, let’s place our attention on prevention of the overall pathology related to diabetes mellitus, and by deductive reasoning, its complications, such as diabetic foot disease.
Conventional wisdom and literature searches recounts the customary recommendations regarding loss of weight, developing an exercise regime, incorporating dietary changes, blood sugar management; and for the feet, taking care of your feet.
Experts are now elucidating other factors besides these that need to be addressed in addition to the standard foot care recommendations for persons with diabetes. (8)
Let’s now consider the subject of non-compliance and non-adherence. (9) It is important to differentiate between the concept of “compliance” and “adherence”. Most health care providers use these two terms interchangeably, when it fact they have two distinct meanings.
Compliance has been defined as “the extent to which a person’s behavior coincides with medical advice”. Non-compliance then essentially means that a patient disobeys the advice of their health care provider.
Adherence, on the other hand, has been defined as the “active, voluntary, and collaborative involvement of the patient in a mutually acceptable course of behavior to produce a therapeutic result”.
The two most common models of care implemented to treat and address the chronic healthcare needs of the person with diabetes are each individually based on either the concept of compliance or adherence. There are significant advantages and disadvantages to each.
First, there is the provider-directed model that can be thought of as the traditional approach, which centers on the patient-physician relationship. Patients who feel that their physicians communicate well with them and actively encourage them to be involved in their own care tend to more compliant. If a deep sense of trust is established in this relationship and patients believe that their physician is someone who can understand their unique patiental experience, providing them with reliable and honest advice that is permeated with compassionate expression, then patient outcomes are greatly improved. On the other hand, if the patient-physician relationship is not optimal, the patient can feel blamed for their non-compliance often being ascribed to negative personal qualities such as forgetfulness, lack of will power, discipline, or low level of education. This sets up a negative judgment toward the patient, leaving the patient totally out of the decision making loop, perhaps avoiding possible negotiable compromises that might have improved the patient’s participation in their care. Concordance between physician and patient, restoration of mutual responsibilities and patient involvement in the decision loop are all vital to the success of the provider-directed model.
Secondly, there is the collaborative model of care.
In the care of acute health care conditions, provider-directed, compliance-oriented care may be very helpful. However, for treatment of chronic illnesses such as diabetes mellitus, this model of collaborative or co-managed care is more effective at
setting goals and providing on-going support for optimal patient self-management behaviors over time, allowing patients to internalize these, making them a more permanent part of their health management construct.
Implicit in this concept is choice and mutual goal setting, treatment planning as well as implementation of the treatment regimen. The health care team is clearly identified; each member is a true partner in the outcome. Patients are encouraged to adhere to these mutually agreed upon guidelines. In this approach patients are taught to be fully responsible for diabetes self-management and in control of decision-making. Providers function in the background when it comes to the daily decisions that patients make to manage their diabetes, making them less dependent on their physicians and more dependent on their own knowledge base. Cooperation and respect are vital to cultivate the adult-to-adult relationship that promotes empowered patients and characterizes collaborative care of the patient with their health team. Provider advice, given in the context of this model, which recognizes the priority of patient decision-making, works very effectively in this set of patients with diabetes who suffer from loss of sensation in their limbs.
An important, yet little reported, area of patient-centered collaborative care, where self-management is the cornerstone, is the recognition and acknowledgment that chronic disease self-management takes a lot of time for patients and possibly their families. Diabetes self-care stands out as especially time-consuming where addressing such things as exercise, dietary changes, self-testing of glucose, administering multiple medications, taking care of your feet and a host of other diabetes related tasks can certainly be challenging from a time-management perspective.
It is generally acknowledged that non-compliance/non-adherence rates for chronic illness regimens and for lifestyle changes can range from 50-70%. As a group, patients with diabetes are no exception; and are especially prone to substantial problems in this regard. This commonality and universality begs the questions: Why? And what can be done?
Given providers who are committed to the Hippocratic oath, they might pose the question: is this non-compliance and non-adherence not part of the disease? Isn’t this a part of the clinical profile that health care providers should be able and willing to recognize and treat? Or do they turn a blind eye and blame the person in question? What about self-responsibility?
To answer these questions, it is important to understand that patient non-adherence or noncompliance can result from many factors. These might be explained by something very simple, such as the advice given to patients by their healthcare professionals is being misunderstood, were carried out incorrectly, forgotten, or even completely ignored. Even challenges with hearing or different languages need to be considered.
Demographic factors such as being an ethnic minority, in a low socioeconomic class and having a low level of education are strongly related to this issue. Belief systems, perceived seriousness of diabetes and its complications, psychological issues, such as stress, mal-adaptive coping mechanisms, anxiety, depression,
alcoholism, drug abuse and dual diagnosis, put patients at risk for ignoring their recommended treatment regimen and poor engagement in their own care and suboptimal diabetes management.
Social issues play a pivotal role in the mindset of the insensate or diabetic patient. Greater levels of social support, more family involvement and closer relationships are associated with greater success in diabetes management, compliance and adherence to the recommended regimen; (10) and this serves to buffer the stress of the whole disease process. This is also true in cases where nurse case managers provide the social support. Further, research (11) indicates a significant relationship between diabetes mellitus, aging and falls; (Figure 6) and poorly controlled diabetes puts that person at an even greater risk of falling than if their diabetes were controlled. Support for the elderly person with diabetes by all involved is needed here, to prevent the potentially devastating effects that falls can have.
Our goal then, as health care providers, innovators and reformers is to promote self-responsible behavior and avoid non-compliance and non-adherence problems. Being aware of these multiple factors are needed to accomplish the desired goal of helping our patients help themselves stay healthy.
END PART 1