The topic of pain management remains a minor component of the formal education and training of residents and physicians in the United States. Misguided attitudes concerning acute and chronic pain management, in addition to reservations about the legal aspects of pain management, often translate into a “fear of the unknown” when it comes to narcotic prescription. The intentionally limited scope of this review is to promote an understanding of the laws regulating pain management practices in the United States and to provide recommendations for appropriate pain management assessment and documentation based on the Model Policy for the Use of Controlled Substances for the Treatment of Pain established by the Federation of State Medical Boards of the United States. (J Am Podiatr Med Assoc 100(6): 511–517, 2010)
The utility of wound debridement has expanded to include the management of all chronic wounds, even in the absence of infection and gross necrosis. Biofilms, metalloproteases on the wound base, and senescent cells at the wound edge irreversibly change the physiologic features of wound healing and contribute to a pathologic, chronic inflammatory environment. The objective of this review is to provide surgeons with a basic understanding of the processes of debridement in the noninfected wound. (J Am Podiatr Med Assoc 100(5): 353–359, 2010)
Introduction: A study of 72 subjects conducted in the European Union and Australia assessed the safety and efficacy of Apligraf (Organogenesis, Inc, Canton, Massachusetts), a bilayered cell therapy composed of living keratinocytes and living fibroblasts in the treatment of non-infected, diabetic foot ulcers (DFU). The design and patient population of this study were similar to a 208-subject United States study (Veves et al., 2001), which led to FDA approval of Apligraf for the treatment of DFU. EU patient outcomes were compared and contrasted to established US-based patient outcome parameters.
Methods: Subjects with a non-infected neuropathic diabetic foot ulcer present for at least two weeks were enrolled in these prospective, multicenter, randomized, controlled, open-label studies that compared Apligraf used in conjunction with standard therapy (sharp debridement, standard wound care, and off-loading) against standard therapy alone.
Results: The design, conduct, and patient populations of the EU and US studies were comparable. Pooling of data was able to be performed because of the similarity and consistency of the two studies. Efficacy and safety results remained consistent across studies independent of mean ulcer duration that was significantly longer in the EU study (21 months, compared to 10 months in the US). Reported adverse events through 12 weeks were comparable across treatment groups in the two studies. Multiple efficacy measures consistently demonstrated superiority of Apligraf treatment over control treated groups in both studies. Combining the data from both studies, 55.2% (80/145) of Apligraf subjects had complete would closure by 12 weeks, compared to 34.3% (46/134) of Control subjects (P = 0.0005; Fisher3s exact test), and Apligraf subjects had a significantly shorter time to complete wound closure (P = 0.0004; log-rank test).
Conclusions: Both the EU and US studies exhibited superior efficacy and comparable safety for subjects treated with Apligraf compared to control treated subjects. The similar outcomes of the two studies provide robust, consistent evidence of the benefit of Apligraf in treating geographically disparate DFU patient populations.
Background: Diabetic lower-extremity disease is the primary driver of mortality in patients with diabetes. Amputations at the forefoot or ankle preserve limb length, increase function, and, ultimately, reduce deconditioning and mortality compared with higher-level amputations, such as below-the-knee amputations (BKAs). We sought to identify risk factors associated with amputation level to understand barriers to length-preserving amputations (LPAs).
Methods: Diabetic lower-extremity admissions were extracted from the 2012-2014 National Inpatient Survey using ICD-9-CM diagnosis codes. The main outcome was a two-level variable consisting of LPAs (transmetatarsal, Syme, and Chopart) versus BKAs. Logistic regression analysis was used to determine contributions of patient- and hospital-level factors to likelihood of undergoing LPA versus BKA.
Results: The study cohort represented 110,355 admissions nationally: 42,375 LPAs and 67,980 BKAs. The population was predominantly white (56.85%), older than 50 years (82.55%), and male (70.38%). On multivariate analysis, living in an urban area (relative risk ratio [RRR] = 1.48; P < .0001) and having vascular intervention in the same hospital stay (RRR = 2.96; P < .0001) were predictive of LPA. Patients from rural locations but treated in urban centers were more likely to receive BKA. Minorities were more likely to present with severe disease, limiting delivery of LPAs. A high Elixhauser comorbidity score was related to BKA receipt.
Conclusions: This study identifies delivery biases in amputation level for patients without access to large, urban hospitals. Rural patients seeking care in these centers are more likely to receive higher-level amputations. Further examination is required to determine whether earlier referral to multidisciplinary centers is more effective at reducing BKA rates versus satellite centers in rural localities.
The COVID-19 pandemic has disrupted healthcare, with its far-reaching effects seeping into chronic disease evaluation and treatment. Our tertiary wound care center was specially designed to deliver the highest quality care to wounded patients. Pre-pandemic, we were able to ensure rapid treatment via validated protocols delivered by a co-localized multidisciplinary team within the hospital setting. The pandemic has disrupted our model's framework, and we have worked to adapt our workflow without sacrificing quality of care. Using the modified Donabedian model of quality assessment, we present an analysis of pre- and intra-pandemic characteristics of our center. In this way, we hope other providers can use this framework for identifying evolving problems within their practice so that quality care can continue to be delivered to all patients.