There are currently 24 million Americans — approximately 8 percent of the entire population — living with diabetes.1 Nearly 1.6 million new cases of diabetes are diagnosed in people 20 years and older each year. It is estimated that the number of patients living with diabetes will double to an estimated 48 million people by 2050.1
As a consequence of this drastic increase in the numbers of patients with diabetes, clinicians anticipate a significant increase in diabetes-related complications, including lower extremity complications such as the development of diabetic foot ulcerations (DFUs) and subsequent progression toward lower extremity amputation. We are facing a rising epidemic of limb loss due to the development of DFUs.
The consequences of major amputation in the lower extremity are well understood. Recent data suggests that the mortality rate associated with lower extremity amputation indeed rivals most cancers.2
In addition to soaring mortality rates related to diabetes, the cost of diabetes care has continued to increase and has proven to be a source of significant expenditures of healthcare dollars, costing nearly $175 billion in 2007.1 Of this cost, approximately $116 billion was direct medical costs and an additional $58 billion was indirect costs. Research has demonstrated that, after adjusting for population, age and gender differences, the average healthcare expenditures among those patients living with diabetes were 2.3 times higher than the healthcare expenditures in the non-diabetic patient population.1
There have been numerous attempts to manage both the increasing incidence of DFUs and address the spiraling cost of healthcare related to the management of patients with diabetes. Numerous studies have demonstrated the efficacy of interdisciplinary approaches to the management of this challenging patient population.3-5
The limb salvage teams described in the literature are commonly located around major university settings or in large metropolitan areas. Despite successes in reducing the number of lower extremity amputations in various limb preservation centers (such as those at the University of Arizona or Georgetown University), the majority of patients with diabetes, due to limited access, still rely on community level providers of various specialties to manage their care.
Emphasizing The Value Of Risk Stratification And Preventative Screening
There have been numerous attempts to provide population-based screening and disease management algorithms for patients with diabetes. We can apply these algorithms universally from the largest metropolitan center to the smallest rural community. These screening measures attempt to provide risk classification and stratification among those patients with diabetes.
Risk stratification involves the determination of those factors — such as neuropathy or musculoskeletal deformity — that may lead to negative outcomes in patients with diabetes. Such stratification based upon risk assessment allows the clinician to triage high-risk patients for appropriate, timely intervention. Stratification can also provide treatment and follow-up algorithms that provide continued surveillance for those patients with diabetes who demonstrate reduced overall risk.6
Accordingly, it is vital that clinicians are able to appropriately determine risk. Numerous studies have elucidated the major risk factors for the development of lower extremity ulceration. These risk factors include vasculopathy, loss of protective sensation (LOPS), musculoskeletal deformity, history of a previous amputation and hyperglycemia.7,8
One algorithm that clinicians can utilize to stratify this patient population appropriately is the Foot Risk Classification system.9 Armstrong and Lavery proposed this system, which categorizes patients into four different risk groups and provides suggested treatment and follow-up algorithms.
The U.S. Department of Health and Human Services has created a five-step lower extremity amputation prevention (LEAP) program, which clinicians can utilize in the evaluation of patients with diabetes.10 Developed in 1992, the LEAP program focuses on identifying patients who have LOPS. The program includes annual patient screening, patient education, daily self-inspection, appropriate footwear selection and early management of simple foot problems to reduce risk.
The LEAP Diabetic Foot Screen uses a 5.07 monofilament, which delivers 10 g of force, to identify patients with a foot at risk of developing problems.10 The LEAP system recommends performing an initial foot screen on all patients with diabetes and at least annually thereafter. At-risk patients should present at least four times a year for a check of their feet and shoes to help prevent lower extremity complications.
Improving Access And Actively Engaging Patients As ‘Partners’ In Their Care
Considering the staggering evidence in support of screening measures and risk stratification of patients with diabetes, the question remains as to how best to implement these screening programs where they are most needed to effectively reduce the development of lower extremity ulceration and subsequent non-traumatic amputations.11,12
To be effective, these screening measures and intervention algorithms must be accessible to the patient populations. Therefore, it stands to reason that community-based programs will demonstrate superiority. Indeed, a study demonstrated that following the institutionalization of a LEAP program in a local hospital system in New Jersey, there was a trend toward an overall reduction in the number of lower extremity amputations at participating institutions.13
Furthermore, community programs must partner healthcare providers — such as internists, endocrinologists and podiatric surgeons — with their respective patients. This way, patients assume personal responsibility for their care and become full partners with the healthcare team in preventing foot problems. This promotes patient adherence and accountability through self-management and unity of action. Patient self-management includes appropriate glycemic control as well as daily lower extremity self examination for early detection of pre-ulcerative lesions, blisters, erythema, swelling and callus development, as well as other potential problem areas.
In addition to self-management, community efforts may include the establishment of diabetes support group meetings — not unlike a support group for people who have had amputations — to allow high-risk patients to interact with one another and provide mutual support. Numerous studies have demonstrated the success of group support following amputation in patients with diabetes.14,15 These support groups commonly provide a sense of community and help patients come to terms with their amputation and its consequences.
A variation on this model can provide group interaction and support prior to the need for amputation, a sort of pre-amputation support group that empowers participating high-risk patients to take a more active role in the management of their diabetes.
Indeed, a recent study included the use of group activity in the development and implementation of a multifaceted program in an inner-city healthcare center designed to improve access to care.16 The Diabetes Rewards Issued Via Everyone (DRIVE) Day program included monthly group visits as well as patient selected activities including diabetes education, nutrition, exercise, group discussions and Q&A sessions. The program also entailed provider support including evidence-based medicine guidelines for glycemic, lipid and hypertension management as well as retinal screening, lower extremity exams and medication adjustment. In addition, DRIVE used a Web-based registry of participants for future reference.
Utilizing the DRIVE Day protocol, clinicians in Cook County, Ill., were able to significantly improve access and efficacy of care for their diabetic patient population despite limited resources.16 Clinicians also had an opportunity for patients with diabetes to take a more active role in their care.16
Considering the significant risk associated with the development of DFUs and subsequent progression toward lower extremity amputation, it is incumbent upon those clinicians involved in the care of patients with diabetes to implement screening processes that can help to prevent lower extremity ulcerations.
Community-based programs, which partner the patient and healthcare provider and empower the patient to take a more active role in the management of their disease process, have demonstrated efficacy. Such programs can provide clinicians an opportunity to perform preemptory screening and risk stratification among these high-risk patients, and triage these patients toward appropriate, timely intervention. This limits the comorbidity and mortality associated with the lower extremity manifestations of diabetes.
Dr. Fitzgerald is in private practice at Hess Orthopaedics and Sports Medicine in Harrisonburg, Va. He is an Associate of the American College of Foot and Ankle Surgeons.
Dr. Steinberg is an Assistant Professor in the Department of Plastic Surgery at the Georgetown University School of Medicine in Washington, D.C. Dr. Steinberg is a Fellow of the American College of Foot and Ankle Surgeons.
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