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Outcomes and Cost Implications of Amputation Prevention in Patients with Diabetes

"In the thirty-ninth year of his reign, King Asa was afflicted with a disease in his feet. Though this disease was severe, even in his illness he did not seek help from the Lord, but only from the physicians. Then in the forty-first year of his reign Asa died and rested with his fathers" -- 2 Chronicles 16:12-44

Diabetes is a challenge for the people who have it, for the health care professionals who care for them, and for the third party carriers who have to pay for the care. The goal of reducing amputations in this population remains elusive, although the steps necessary seem intuitive when considered in terms of "pathways to amputation." Simple strategies should be able to achieve the twin goals of managed care--improving outcomes while decreasing costs. When prophylactic care fails and the foot breaks down, aggressive wound care, aggressive vascular surgery and the multidisciplinary diabetic foot clinic can often retrieve the situation, achieving the same goals. This presentation analyzes the cost implications of lower extremity amputation prevention in this difficult population.

Magnitude of the problem:

There is a huge expense associated with diabetic foot problems. Feet account for 16% of hospital admissions for diabetes. Feet account for 23% diabetic hospital days. Foot ulcers occur in 15% of diabetics. Almost half of diabetics are neuropathic at 20 years. Traditional wound care is not very effective in healing the ulcers that become chronic. Many of these result in amputation. Over half of the major amputations occur in diabetics, and at least a third of these amputees loose the opposite leg within the next 3 years. The direct medical costs are high enough to mandate definitive action. The social costs, in terms of time off work, disability and dependency, although not the subject of this analysis, are even greater. In spite of these statistics only 12% of physicians routinely examine the feet.

Pathways to amputation:

The pathophysiology of the diabetic foot is interesting, but beyond the scope of this presentation. Suffice it to say that the diabetic foot not only looses its protective sensation, but it also looses motor innervation of the small muscles of the foot (the hand is affected as well). It also looses sympathetic innervation leading to a foot which is physically warm but it is ischemic. The unwary physician is commonly misled. Glycosylation of the tissues makes them less flexible and compounds the problem of neuropathy.

Analyzing strategies for amputation prevention in terms of specific complications of diabetes is a daunting task. Analyzing strategies for amputation prevention in terms of the "Pathways to Amputation" is easier. Each pathway has an intervention point early on which is inexpensive and quite effective.

Pathway #1: Arterial Insufficiency, Minor Injury, Gangrene, Amputation. In this pathway early intervention is the key. Diagnosis is made early in the Vascular Laboratory. Aggressive diagnosis and vascular surgery by experts should prevent 70% of amputations. "Diabetic microvascular disease" is a misnomer. Surgeons who believe that the tibial vessels cant be bypassed should not be trusted with these patients. Aggressive diagnosis and vascular surgery by experts should prevent 70% of the amputations that occur at the end of this path.

Pathway #2: Poor Care, Callus, Neuropathy, Blister under Callus, Infection, Osteomyelitis, Amputation. The key to this pathway is good foot care. All of the amputations that occur at the end of this path should be preventable.

Pathway #3: Neuropathy, Structural Deformity, Minor Trauma, Poor Healing, Infection, Gangrene, Amputation. The key to this pathway is use of the Semmes monofilament wire to detect the absence of protective sensation coupled with early intervention with education, foot care and protective foot gear. Almost all of the amputations that occur at the end of this path should be preventable.

Pathway #4: Renal Insufficiency, Poor Tissue, Poor Healing, Minor Injury, Infection, Amputation. This is a difficult group of patients. Amputation prevention in these patients is possible only in patients whose functional state is good and whose medical condition is good. Only about half of these amputations are preventable. There is little hope for the patients who are approaching life's end whose gangrenous leg is the first step in a terminal condition.

Pathway #5: Autosympathectomy, Poor Care, Dry Skin, Fissuring, Infection, Amputation. Good skin care with over the counter emollients should prevent all of these amputations. Don't forget superglue to close early cracks.

Managing the cost of diabetes.

Most of the effective strategies for managing the cost of the complications of diabetes are intuitive. Much can be said about the importance of glycemic control in the prevention of complications. Treatment of micro proteinuria is equally important. Routine foot care self-provided by the patient and routine patient examination of his or her own feet is important as well. It should also be intuitive that complex problems managed early are associated with less morbidity and less cost. Futile care for a patient with a major foot infection should be avoided. A determination should be made early on as to whether a wound is healable, whether the patient is a candidate for limb salvage surgery, or if the patient is a candidate for amputation. Amputations when done should done early after infection is controlled, and should be guided by the vascular laboratory to insure that the initial amputation will heal. Consideration should be given to two stage amputations when infection is uncontrolled. Patients who do not use an extremity are candidates for early amputation rather than limb salvage. Both money and suffering are saved by this strategy.

Unfortunately all medical care is not equal. Compliance is a problem as well. Some patients do not comply with treatment recommendations. Some physicians do not comply with effective management protocols. The following cost analysis assumes that care is being provided by competent, well trained teams of providers. Unfortunately not all internists are qualified to care for diabetes. Not all people holding themselves out as vascular surgeons have specific training and certification in that specialty. Not all self styled wound care specialists have the requisite diagnostic skills to deal with these complex problems.

Cost implications of diabetic foot wounds and their treatment:

Cost implications are best summarized by the published data which is detailed on the slides used in this talk. I will provide only the highlights here and the slides are attached.

Cost of diabetic foot ulcers:

The cost to care for diabetic foot wounds depends on which wounds are studied. For the purposes of this analysis only chronic wounds are considered. Such wounds predict an additional cost of $14 000 per patient per year for 2 years, the same as the direct cost of an amputation. Only one third are healed by conventional therapy. That a comprehensive wound care program can heal 80% of these patients has been demonstrated repeatedly. The costs are front end loaded, but should be less than the average cost of conventional care in the first year. Clinics able to achieve such results are generally multidisciplinary. Their care is protocol driven and results oriented. Their leaders are primarily diagnosticians and not dressing merchants. Patient education features prominently in what they do.

Cost of vascular reconstruction vs primary amputation:

The cost of revascularization, even in diabetics with cardiovascular disease, is driven by the extent of the necrotic tissue and not the operation or the other comorbidities. Vascular patients with diabetes commonly require tibial bypasses and this operation is outside of the scope of practice of most general surgeons and cardiac surgeons not making vascular surgery a specialty. These grafts require maintenance dictated by a graft surveillance program. Surveillance studies may or may not be considered a covered benefit but should be. All of this is expensive. Primary amputation is more expensive, however, even when only the direct costs of health care are considered. Amputations have maintenance costs as well. The incidence of reamputation, new amputations, and stump ulcerations is high in these patients. Prosthetic costs approximate the cost of a new car every 3 or 4 years. Since most diabetic patients undergoing major amputation do not regain their ability to walk, indirect costs of amputation are even higher. Limb salvage vascular surgery is less expensive than primary amputation.

Cost of specialized diabetic foot programs:

There are no easy answers to the medical management of diabetic foot problems. Simply providing a "shoe benefit" is ineffective. An effective program couples risk assessment with targeted interventions. Such interventions may include education, extra depth shoes, inserts, custom shoes, trimming nails and calluses, casting and a host of others. High risk patients may need to see a specialist on a monthly basis for routine care. The few available studies of the cost effectiveness of this approach are summarized, and are compelling. In Denver this service is best provided by the podiatrists.

Diabetic foot wounds are a challenge. The best interventions are the ones taken before the wound occurs. These interventions are inexpensive and effective. For patients with chronic wounds, however, comprehensive wound management programs, aggressive revascularization strategies, and specialized foot care programs are prudent financial investments.

Dr Brantigan wrote this article in December of 2000.

2003-2004 Dr. Charles Brantigan,  Vascular Surgery Practice
2253 Downing Street, Denver, CO 80205
303.830.8822 fax: 303.830.7068 or 800.992.4676  inquiries@drbrantigan.com

Last Updated: 07/15/2004