Abstract and Introduction
Abstract
Background. This literature review serves to develop an evidence-based algorithm for the treatment of venous ulcerations and the development of a guideline to systemically treat venous leg ulcerations (VLUs) that may improve outcomes, restore function of the affected limb, and reduce health care costs.
Methods. The Cochrane Database and PubMed search engine were utilized to accumulate literature concerning venous ulcerations and their treatment. The most relevant literature was reviewed to develop an algorithm to guide treatment of VLUs.
Results. An algorithm was established outlining the use of compression therapy in VLUs present for < 4 weeks. If a wound is present after 4 weeks of therapy and has not reduced in size by ≥ 40%, bilayered living skin equivalents may be indicated.
Conclusion. An algorithm was established to guide the treatment of venous ulcerations. By utilizing a systematic approach in treating VLUs, clinical outcomes may be improved.
Introduction
The treatment of chronic venous disease (CVD) and its complications can be frustrating. Chronic venous disease can be defined as an abnormally functioning venous system caused by venous valvular incompetence with or without associated venous outflow obstruction. Venous leg ulcers (VLUs) are defined as an area of discontinuity of epidermis and dermis on the lower leg, persisting for 4 weeks or more. The occurrence of venous leg ulcer is strongly associated with venous disease (eg, varicose veins and deep vein thrombosis) contributing to sustained venous hypertension; arterial disease is present (alone or in combination with venous disease) in approximately 20% of cases. The etiology of VLUs includes inflammatory processes resulting in leukocyte activation, endothelial damage, platelet aggregation, and intracellular edema. Other factors contributing to VLUs include immobility, obesity, trauma, vasculitis, older age, diabetes, and neoplasia. Outflow obstruction, valvular obstruction, and venous hypertension contribute to venous ulceration risk. Arterial and ischemic ulcerations generally occur on the anterior tibia, lateral leg, and distal toes, all areas which are susceptible to trauma. The inability to heal these wounds stems from vascular congestion and artherosclerotic changes, particularly in the feet and toes. The accepted statistics indicate that VLUs require an average of 24 weeks to heal; approximately 15% never heal; and recurrence is found once or multiple times in 15%-71% of cases. In reported populations of venous ulcers, 15%-71% are found to be recurrent lesions. Healed ulcerations possibly can have a 5-year recurrence rate as high as 40%.
Venous leg ulcers are a common chronic recurring condition and a major cause of morbidity and disability. Epidemiological evidence suggests that approximately 1% of the United States (US) adult population, or about 3 million Americans, have VLUs. The prevalence of VLUs increases with age, with rates of about 8% in patients > 80 years. Approximately 1.7% of persons > 60 years develop a new VLU within 2 years.
Venous leg ulcer outcomes are optimized when patients receive multidisciplinary care and evidence-based wound management. Dermatology, geriatrics, podiatry, and surgery are just a few specialties that may be utilized to improve outcomes. Adherence to multidisciplinary guidelines was associated with 6.5-fold and 2.5-fold increases in the likelihood of healing among US and British patients with VLUs, respectively. Significant decreases in healing time and costs were also associated with guideline adherence. Among veterans with VLUs, those who receive guideline-concordant wound care are 2.5 times more likely to achieve wound healing than are those who receive nonconcordant care.
Several comprehensive clinical guidelines for the diagnosis and management of VLUs have been developed in recent years, but the widespread implementation of evidence-based VLU management has not been achieved. Common barriers to the adoption of VLU consensus guidelines include misdiagnosis, under-recognition of VLUs, inadequate training, absence of structured care delivery plans, and lack of coordination among providers. The costs of VLUs include direct costs associated with medical resource utilization, indirect costs related to loss of productivity, and patient impact. In 2006, Khan and Davies stated that the direct treatment costs of VLUs in the US are about $1 billion annually, and that the average lifetime cost of VLUs for 1 patient exceeds $400,000. In 2011, O'Donnell and Balk wrote "the management of VLUs consumes considerable resources in health care systems and accounts for up to 1% of health care budgets in some industrialized countries." The indirect costs of VLUs are primarily due to time lost from work because of illness or disability. Since the treatment of VLUs often involves multiple office visits for debridement, dressing changes, and other procedures, and VLU may be associated with significant loss of productivity and ability to engage in leisure activities, these costs are likely to be substantial.
Gelfand et al conducted a large cohort study examining 56,488 venous ulcerations. A venous ulceration was defined in the study as a chronic wound of the lower extremity in the gaiter area. These wounds were less than 2 cm in depth and did not involve tendon, ligament, or bone and were less than 150 cm. The study concluded that change in wound area at 4 weeks was a strong indicator of healing at 12 weeks or 24 weeks. When examining full thickness ulcerations however, van Rijswijk found that > 30% reduction in ulcer area at 2 weeks of treatment was a predictor of both treatment outcome and time required for healing. The depth of the ulceration is an important consideration as full thickness wounds take longer to heal. When comparing partial thickness venous ulcerations and full thickness ulcerations, full thickness wounds take approximately twice as long to heal.
An additional factor in predicting healing time and potential is ulcer duration. Margolis et al evaluated 260 patients over a 2-year period with chronic venous ulcerations. The patients received weekly multilayered compressive dressings. The study found that those wounds that were < 5cm and those ulcerations present for < 6 months were more likely to heal by week 24. The multilayered compressive dressings healed 85% and 88% of these wounds, respectively.
Comorbid illnesses are common in patients with VLUs and may contribute to delayed wound healing and an increased risk of VLU recurrence. Performing a comprehensive clinical history and physical examination is critical to the identification of underlying comorbidities and provides important information regarding the etiology of VLUs. Management decisions in patients with chronic VLUs are often influenced by comorbidities. Factors such as obesity, malnutrition, intravenous drug use, and coexisting medical conditions may affect prognosis and suitability for invasive and noninvasive interventions. When VLUs fail to respond to treatment or heal in a timely manner, clinicians should consider further diagnostic investigations and referral to specialists to identify occult etiologies and ensure underlying comorbidities are being adequately addressed through a multidisciplinary approach.
The purpose of this review is to establish an evidence-based algorithm for treating venous ulcerations by utilizing a systematic review of the Cochrane Database.