Robert G. Frykberg

Comprehensive Foot Examination and Risk Assessment A report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists

It is now 10 years since the last technical review on preventative foot care was published (1), which was followed by an American Diabetes Association (ADA) position statement on preventive foot care in diabetes (2). Many studies have been published proposing a range of tests that might usefully identify patients at risk of foot ulceration, creating confusion among practitioners as to which screening tests should be adopted in clinical practice. A task force was therefore assembled by the ADA to address and concisely summarize recent literature in this area and then recommend what should be included in the comprehensive foot exam for adult patients with diabetes. The committee was cochaired by the immediate past and current chairs of the ADA Foot Care Interest Group (A.J.M.B. and D.G.A.), with other panel members representing primary care, orthopedic and vascular surgery, physical therapy, podiatric medicine and surgery, and the American Association of Clinical Endocrinologists. The lifetime risk of a person with diabetes developing a foot ulcer may be as high as 25%, whereas the annual incidence of foot ulcers is ∼2% (3–7). Up to 50% of older patients with type 2 diabetes have one or more risk factors for foot ulceration (3,6). A number of component causes, most importantly peripheral neuropathy, interact to complete the causal pathway to foot ulceration (1,3–5). A list of the principal contributory factors that might result in foot ulcer development is provided in Table 1. View this table: Table 1— Risk factors for foot ulcers The most common triad of causes that interact and ultimately result in ulceration has been identified as neuropathy, deformity, and trauma (5). As identification of those patients at risk of foot problems is the first step in preventing such complications, this report will focus on key components of the …

The Charcot Foot in Diabetes

The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.

Challenges in the Treatment of Chronic Wounds

Significance: Chronic wounds include, but are not limited, to diabetic foot ulcers, venous leg ulcers, and pressure ulcers. They are a challenge to wound care professionals and consume a great deal of healthcare resources around the globe. This review discusses the pathophysiology of complex chronic wounds and the means and modalities currently available to achieve healing in such patients. Recent Advances: Although often difficult to treat, an understanding of the underlying pathophysiology and specific attention toward managing these perturbations can often lead to successful healing. Critical Issues: Overcoming the factors that contribute to delayed healing are key components of a comprehensive approach to wound care and present the primary challenges to the treatment of chronic wounds. When wounds fail to achieve sufficient healing after 4 weeks of standard care, reassessment of underlying pathology and consideration of the need for advanced therapeutic agents should be undertaken. However, selection of an appropriate therapy is often not evidence based. Future Directions: Basic tenets of care need to be routinely followed, and a systematic evaluation of patients and their wounds will also facilitate appropriate care. Underlying pathologies, which result in the failure of these wounds to heal, differ among various types of chronic wounds. A better understanding of the differences between various types of chronic wounds at the molecular and cellular levels should improve our treatment approaches, leading to better healing rates, and facilitate the development of new more effective therapies. More evidence for the efficacy of current and future advanced wound therapies is required for their appropriate use.

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers.

OBJECTIVETo compare healing rates at 12 weeks for full-thickness diabetic foot ulcers treated with OASIS Wound Matrix, an acellular wound care product, versus Regranex Gel. DESIGNRandomized, prospective, controlled multicenter trial at 9 outpatient wound care clinics. SUBJECTSA total of 73 patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol. INTERVENTIONPatients were randomized to receive either OASIS Wound Matrix (n = 37) or Regranex Gel (n = 36) and a secondary dressing. Wounds were cleansed and debrided, if needed, at a weekly clinic visit. Dressings were changed as needed. The maximum treatment period for each patient was 12 weeks. PRIMARY OUTCOME MEASUREIncidence of healing in each group at 12 weeks. RESULTSAfter 12 weeks of treatment, 18 (49%) OASIS-treated patients had complete wound closure compared with 10 (28%) Regranex-treated patients. CONCLUSIONAlthough the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior (P = .055), the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks.

Postoperative Infection Rates in Foot and Ankle Surgery: A Comparison of Patients with and without Diabetes Mellitus

BACKGROUND Patients with diabetes mellitus may be at increased risk for infection following foot and ankle surgery. This study aimed to determine whether patients with a diagnosis of diabetes mellitus have an increased rate of infection following foot and ankle surgery compared with a cohort of patients without diabetes. Furthermore, our study sought to demonstrate whether patients with complicated diabetes are at greater risk of postoperative wound infection than are patients with uncomplicated diabetes or patients without diabetes. METHODS We conducted a retrospective review of the charts of 1000 patients who had orthopaedic foot and ankle surgery. The following data were extracted: patient age, sex, history of diabetes mellitus, development of postoperative infection, severity of infection, inpatient or outpatient surgery, use of internal or external fixation, tobacco use, history of organ transplantation, history of rheumatoid arthritis, length of surgery, follow-up time in weeks, and comorbid conditions. RESULTS The overall infection rate in this study was 4.8%. Fifty-two percent of all infections occurred in our diabetic study group, which represented only 19% of the patient population. Postoperative infections occurred in significantly more persons with diabetes (13.2%) than in those without diabetes (2.8%). Diabetic patients were five times more likely to experience a severe infection requiring hospitalization compared with patients without diabetes. After removing the patients with neuropathy from the analysis, there was no longer a significant association between diabetes and infection. The presence of complicated diabetes increased the risk of postoperative infection by a factor of ten compared with the risk for patients without diabetes and by a factor of six compared with the risk for patients with uncomplicated diabetes. We did not identify a significantly increased risk of infection in patients with uncomplicated diabetes compared with that in patients without diabetes. CONCLUSIONS Patients with diabetes mellitus are at increased risk of severe infection compared with those without diabetes. Patients with uncomplicated diabetes did not have an increased risk of postoperative infection compared with patients without diabetes, whereas patients with complicated diabetes had a significantly higher rate of postoperative infection.

Epidemiology of the Charcot Foot

The Charcot foot (osteoarthropathy) is a significant lower extremity complication of diabetes mellitus that can result in significant deformity, ulceration, and subsequent limb loss. A result of even unrecognized trauma to an insensitive foot, continued weight bearing on the injured foot promotes the evolution of the disorder that is often diagnosed only after significant deformity has occurred. Although this entity is considered a rare complication of the diabetic population, it has profound implications for those persons affected. Greater awareness of the frequency, distribution, determinants, and natural history of Charcot foot can help clinicians establish an earlier diagnosis and institute effective treatment before the onset of limb-threatening deformity.

Mortality Risk of Charcot Arthropathy Compared With That of Diabetic Foot Ulcer and Diabetes Alone

OBJECTIVE The purpose of this study was to compare mortality risks of patients with Charcot arthropathy with those of patients with diabetic foot ulcer and those of patients with diabetes alone (no ulcer or Charcot arthropathy). RESEARCH DESIGN AND METHODS A retrospective cohort of 1,050 patients with incident Charcot arthropathy in 2003 in a large health care system was compared with patients with foot ulcer and those with diabetes alone. Mortality was determined during a 5-year follow-up period. Patients with Charcot arthropathy were matched to individuals in the other two groups using propensity score matching based on patient age, sex, race, marital status, diabetes duration, and diabetes control. RESULTS During follow-up, 28.0% of the sample died; 18.8% with diabetes alone and 37.0% with foot ulcer died compared with 28.3% with Charcot arthropathy. Multivariable Cox regression shows that, compared with Charcot arthropathy, foot ulcer was associated with 35% higher mortality risk (hazard ratio 1.35 [95% CI 1.18–1.54]) and diabetes alone with 23% lower risk (0.77 [0.66–0.90]). Of the patients with Charcot arthropathy, 63% experienced foot ulceration before or after the onset of the Charcot arthropathy. Stratified analyses suggest that Charcot arthropathy is associated with a significantly increased mortality risk independent of foot ulcer and other comorbidities. CONCLUSIONS Charcot arthropathy was significantly associated with higher mortality risk than diabetes alone and with lower risk than foot ulcer. Patients with foot ulcers tended to have a higher prevalence of peripheral vascular disease and macrovascular diseases than patients with Charcot arthropathy. This finding may explain the difference in mortality risks between the two groups.

Surgical Site Infections After Foot and Ankle Surgery: A Comparison of Patients With and Without Diabetes

OBJECTIVE This prospective study was designed to evaluate the rate of surgical site infection (SSI) after foot and ankle surgery in patients with and without diabetes. RESEARCH DESIGN AND METHODS The study prospectively evaluated 1,465 consecutive foot and ankle surgical cases performed by a single surgeon. RESULTS The overall SSI rate in this study was 3.5%, with significantly more infections occurring in individuals with diabetes than in those without (9.5 vs. 2.4%, P < 0.001). Peripheral neuropathy, Charcot neuroarthropathy, current or past smoking, and increasing length of surgery were significantly associated with SSI on multivariate analysis. CONCLUSIONS This study demonstrates significant associations between the development of SSI and chronic complications of diabetes. We confirm previous findings that it is peripheral neuropathy and not diabetes itself that most strongly determines the development of postoperative infections in these surgical patients.

Complications encountered with circular ring fixation in persons with diabetes mellitus.

Background: The purpose of this study was to identify and report the complications associated with the use of circular ring fixation in diabetic patients, and to compare the frequency of complications in patients without diabetes. We hypothesized that complications with circular ring fixation occurred more frequently in patients with diabetes than patients without diabetes. Materials and Methods: Institutional Review Board approval was obtained and patient charts were retrospectively reviewed from June 2004 and February 2007. Fifty six consecutive patients undergoing midfoot, hindfoot and/or ankle surgery were treated with circular ring fixation which included 33 diabetic patients in the study group and 23 non-diabetic patients in the control group. Patient demographics, the duration of treatment with the external fixator, and complications were recorded. Results: Males had a greater number of complications compared to females (p = 0.0014). The total number of complications was statistically greater in diabetic patients (study group) versus non-diabetic patients (control group) (p = 0.003). In multivariate logistic regression, diabetes and male sex were the only significant variables associated with wire complications (OR 7.35, 95% CI 1.93-28.04 and OR 0.22, 95% CI 0.05-8584111, respectively). Conclusion: Women are protected from wire complications with a risk reduction of 78% compared to males. Diabetics have a 7-fold risk for any wire complication compared to patients without diabetes. We found no adverse effects of BMI, obesity, age, smoking, neuropathy, or Charcot neuroarthropathy on a satisfactory recovery. Level of Evidence: IV, Retrospective Case Study

Neuropathy and Poorly Controlled Diabetes Increase the Rate of Surgical Site Infection After Foot and Ankle Surgery

BACKGROUND This prospective study was designed to evaluate the frequency of surgical site infection in patients treated with foot and ankle surgery. Our hypothesis was that patients with complications of diabetes are at increased risk for surgical site infection compared with patients without diabetes and patients with diabetes who do not have diabetic complications. Another goal was to compare the association of neuropathy with surgical site infection in both nondiabetic and diabetic patients. METHODS Two thousand and sixty consecutive surgical cases were evaluated. Group 1 included nondiabetic patients without neuropathy, Group 2 included nondiabetic patients with neuropathy, Group 3 included patients with diabetes but no diabetic complications, and Group 4 included patients with diabetes who had at least one complication of diabetes. RESULTS The surgical site infection rate in this study was 3.1%. Patients with complicated diabetes had a 7.25-fold increased risk of surgical site infection compared with nondiabetic patients without neuropathy and a 3.72-fold increased risk compared with patients with uncomplicated diabetes. Patients with complicated diabetes had a nonsignificant 1.54-fold higher rate of surgical site infection compared with nondiabetic patients with neuropathy. Nondiabetic patients with neuropathy had a significant 4.72-fold increased risk of surgical site infection compared with nondiabetic patients without neuropathy. Despite this, nondiabetic patients with neuropathy did not have a significantly higher rate of surgical site infection than patients with uncomplicated diabetes, and the frequency of surgical site infection in the group with uncomplicated diabetes was not significantly different from that in the nondiabetic patients without neuropathy. Multivariable logistic regression analysis demonstrated that peripheral neuropathy and a hemoglobin A1c of ≥8% were independently associated with surgical site infection. CONCLUSIONS Complicated diabetes increases the risk of surgical site infection after foot and ankle surgery. Patients who had diabetes without complications did not have a greater risk of surgical site infection compared with nondiabetic patients without neuropathy. The presence of neuropathy increases the risk of surgical site infection even in patients without diabetes. Poor long-term glycemic control is also associated with an increased risk of surgical site infection. LEVEL OF EVIDENCE Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence.