An Evidence-Based Algorithm for Treating Venous Leg Ulcers Utilizing the Cochrane Database of Systematic Reviews

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.

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.¹ 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.² 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.³ 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.⁴ 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.^5,6 In reported populations of venous ulcers, 15%-71% are found to be recurrent lesions.⁷ Healed ulcerations possibly can have a 5-year recurrence rate as high as 40%.⁸   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.^9,10 The prevalence of VLUs increases with age, with rates of about 8% in patients > 80 years.¹¹ Approximately 1.7% of persons > 60 years develop a new VLU within 2 years.¹²   Venous leg ulcer outcomes are optimized when patients receive multidisciplinary care and evidence-based wound management.^13,14 Dermatology, geriatrics, podiatry, and surgery are just a few specialties that may be utilized to improve outcomes.¹⁵ 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.¹⁶ 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.¹⁷   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.^18,19 The costs of VLUs include direct costs associated with medical resource utilization, indirect costs related to loss of productivity, and patient impact.¹⁹ In 2006, Khan and Davies²⁰ 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 Balk²¹ 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 al²² 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 cm². 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 Rijswijk²³ 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.²⁴ When comparing partial thickness venous ulcerations and full thickness ulcerations, full thickness wounds take approximately twice as long to heal.²⁴   An additional factor in predicting healing time and potential is ulcer duration. Margolis et al²⁵ 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 < 5cm² 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.²⁵   Comorbid illnesses are common in patients with VLUs and may contribute to delayed wound healing and an increased risk of VLU recurrence.^26,27 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.

The algorithm is based on information obtained from multiple sources including the Cochrane Database of Systematic Reviews, the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system, and large VLU cohort studies. In reviewing literature for this algorithm, the Cochrane Database and PubMed were searched. Specific key words included in the search were “VLU algorithm,” “history of venous ulcers,” “treatment of venous ulcers,” “factors affecting VLUs,” “CEAP classification,” and “VLU dressings.” Literature from 1990 to present were included. Cochrane Database revealed 27 publications and the most relevant articles were reviewed. The opinions of clinicians knowledgable in the treatment of VLUs and the most common treatment modalities were used to determine relevance of the modalities chosen. Minimal and low randomized control trials were excluded from the review.   The Cochrane Database of Systematic Reviews is an independent and collaborative source of information about the effects of health care interventions, prepared by > 28,000 independent contributors working in > 100 countries.

Over the years, clinicians have been faced with numerous treatments for VLUs. Some current products and treatments have minimal to no evidence to show that they are effective. The goal of the algorithm is to treat VLUs with the best evidence to close them sooner and more cost effectively. The VLU treatment algorithm is shown in Figure 1.   The CEAP classification system was originally developed in 1994 by an international ad hoc committee of the American Venous Forum and adopted worldwide to facilitate meaningful communication about CVD, and to serve as a basis for scientific analysis of CVD and treatment options.²⁸ As shown in the algorithm, the management of a patient with a suspected VLU begins with a comprehensive medical history and detailed physical examination. The medical history should include documentation of previous manifestations of CVD and previous and current ulcers. Preceding episodes of malignancy, vasculitis, collagen-vascular diseases, and dermal manifestations of systemic diseases should be identified. Suspected chronic VLUs that increase in size after debridement, or are excessively painful, should be reevaluated for possible underlying etiologies.   An important goal of the physical examination is to document or exclude the presence of CVD. Physical examination should include evaluation of ulcers, venous dilatation, edema, skin pigmentation, and venous refill time. A detailed history should be performed, especially if there is a healed or active ulcer. If there is a current venous ulcer, a physical exam with descriptive terms is important. The exam should be done with the patient both supine and standing.   Venous dilatation should be described and examined by both visualization and palpation. Description of a dilated vein can range from telangiectases to reticular veins to varicose veins.   Edema indicates the disease has progressed and is functionally advanced. The extent of the edema should be described and the limbs should be circumferentially measured.   Skin pigmentation changes, such as venous eczema and lipodermatosclerosis, are important signs of severe chronic disease. Any and all pigmentation changes should be described.   Venous ulceration is the sign of the most advanced disease. The location and the measurement of the ulcer should be well described, along with any healed ulcers that have scarring.   Venous refill time provides an overall measurement of venous reflux. Venous leg ulcers may exist in the presence of mixed arterial/venous pathology, and treatment of only the elevated venous pressure will be unsuccessful when significant arterial disease is present. Gross arterial disease should be ruled out by establishing that pedal pulses are present on physical examination and/or that the ankle brachial index (ABI) is > 0.8. If concurrent arterial disease is present, this should be evaluated and addressed. When present, patients should not have traditional compressive dressings. The complexity of the diagnostic work-up is influenced by the severity of the clinical problem and the degree of disability. An international consensus conference was held in 1994 at the American Venous Forum to develop a new classification system of CVD. The CEAP classification was developed and implemented,^29,30 and is broken down into 4 components:   Clinical classification. There are 7 clinical classes from 0 to 6, with 0 indicating no disease; 1 indicating signs of telangiectasia or reticular veins; 2 indicating varicose veins; 3 indicating edema without skin changes; 4 indicating skin changes associated with venous disease; 5 indicating skin changes with healed ulcers; and 6 indicating skin changes with active ulceration.   Etiologic classification. The type of dysfunction is classified as either congenital, primary, or secondary. Congenital dysfunctions are noted at birth, but don’t manifest until later in life. Primary dysfunction is of an unknown cause, while secondary dysfunction is an acquired condition such as deep vein thrombosis.   Anatomic classification. Anatomic sites of venous disease are either superficial, deep, and/or perforating. One system or all systems simultaneously can be involved in the same time.   Pathophysiologic classification. Signs or systems of CVD result from reflux, obstruction, or both. This classification system is very detailed and can be used to direct treatment for surgical vs conservative treatment. The one fault of the system is that there is no classification for other concurrent conditions that might affect the severity or treatment of CVD. Important considerations for other diseases, such as diabetes and lymphedema, need to be taken into account because they might affect the treatment and healing times.   The diagnostic tests useful in CVD have been classified into 3 levels: I = office testing (eg, history, physical examination, and continuous-wave ([handheld] Doppler studies); II = vascular laboratory (eg, duplex scanning, plethysmography, and venous pressure); and III = phlebography (eg, ascending and descending phlebography and varicography). All patients should undergo level I diagnostic studies, in which the minimal degree of objective testing is achieved by the continuous-wave Doppler examination. Level II diagnostic investigations are done for patients with the simplest and most straightforward problems, and level III diagnostic studies are reserved for difficult cases and preoperative planning, especially for patients undergoing deep venous reconstruction.   Baseline clinical features of VLUs can help identify patients who are likely to respond to conservative treatment and those who may require more aggressive interventions. Margolis et al³¹ analyzed a dataset of more than 20,000 patients with VLUs treated with lower limb compression therapy to determine the accuracy of several prognostic models. Initial measures of wound size and duration accurately identified patients who were likely to heal by the 24th week of care. For example, a wound < 10 cm² and < 12 months old at the first visit has a 29% chance of not healing by the 24th week of care, while a wound > 10 cm² and > 12 months old has a 78% chance of not healing. These criteria may help wound care providers decide when to consider using conservative treatments only, or in addition to, adjuvant therapies early in the course of VLU treatment.

The treatment options can be broken down to 5 categories: compression, local wound care, surgical intervention, medical treatment, and advanced technology. Basic wound care principles also need to be followed, such as proper wound environment, control of clinical signs of infection, and debridement. In a recent review of the impact of debridement on healing of VLUs, ulcer surface area reduction was greater in visits after debridement.³² Attention should be paid to removal of all necrotic tissue, densely adherent slough and exudates, and reshaping of the ulcer margins.

The cornerstones of the VLU management algorithm are wound debridement; management of exudate; and wound moisture, infection control, and management of concurrent systemic conditions. Lower limb compression is the standard of care for patients with VLUs without concurrent arterial disease and provides the basis for the initial treatment recommendation in the VLU algorithm. In 2009, the Cochrane Database reported an extensive evaluation of the clinical effectiveness of compression bandage or stocking systems in the treatment of VLU.³³ The analysis was designed to determine if the application of compression bandages or stockings aid VLU healing, and if so, which compression bandage or stocking is the most effective. A total of 39 randomized clinical trials that evaluated any type of compression bandage system or compression hosiery were included in the analysis. The evidence strongly suggests that VLUs heal more rapidly with compression than without, and that multicomponent compression achieves better healing outcomes than single-component systems. When competing systems comprising 2 components were compared, there was some evidence suggesting those including an elastic component may be more effective than those composed mainly of inelastic constituents; a similar finding was noted for alternative 3-component systems.³³   A substantial proportion of patients with VLUs are not helped by compression bandaging, or are unwilling or unable to wear it. Other patients with VLUs may be unsuitable candidates for compression bandaging due to concurrent arterial disease. Intermittent pneumatic compression (IPC) is an alternative method of delivering compression that utilizes an air pump to periodically inflate/deflate bladders incorporated into sleeves applied to affected limbs. Multiple techniques for providing IPC are available using single or multiple chambers/bladders, different types of pumps and compression cycles, and variations in inflation and deflation times.   Clinical evidence of the effectiveness of IPC in increasing healing rates in patients with VLUs was extensively reviewed by Nelson et al³⁴ and reported in the Cochrane Database. A total of 7 randomized controlled trials including 367 patients were included in the analysis. Compared with no compression, IPC was associated with a 2.27-fold increase in the likelihood of VLU healing. Trials of IPC and compression vs compression alone provided inconsistent results, with no differences in healing rates reported in some trials, and modest benefits of combination treatment reported in others. Rapid IPC was associated with greater VLU healing rates and shorter time to complete VLU healing than slow IPC. No significant differences in pain scores were observed between patients receiving IPC and those treated with Unna’s boot.

Wound dressings are usually applied beneath the compression to aid healing, enhance comfort, prevent adherence of the bandage to the ulcer, and control exudate. A wide variety of dressing products and types are available including hydrocolloids, foams, alginates, hydrogels, and others. A Cochrane review of 42 randomized controlled studies with a total of more than 1000 patients found no evidence that any one dressing type was better than others in terms of number of ulcers healed.³⁵ Furthermore, the more expensive hydrocolloid dressings were not shown to provide healing benefits over the lower-cost simple nonadherent dressings. Without clear evidence to support the use of one dressing over another, the choice of dressings for VLUs can be guided by cost, ease of application, and patient and physician preferences.   Studies have shown that modern dressings, particularly if the wound is < 4 weeks old, do not provide a significant improvement in healing rates of chronic venous ulcerations.³⁶ Chaby et al³⁶ concluded that only a weak level of evidence existed for clinic efficacy of products such as hyaluronic acid, hydrogels, and silver-impregnated products when compared to saline or paraffin gauze. Statistical significance in wound healing did not occur in venous ulceration healing until week 6 in a literature review by Kerstein et al.³⁷ Impregnated gauze, hydrocolloid dressings, and human skin constructs were evaluated, and it was concluded that advanced products may not be cost-effective in early treatment. Cambal et al³⁸ conducted a small study of 20 patients with chronic venous ulcerations with compressive sclerotherapy and maggot debridement therapy. In these patients, 95% showed a significant clinical improvement. A review conducted by Simms and Ennen³⁹ determined that no dressing was superior to another, and compression is the necessary gold standard of treatment.

The use of systemic agents should be considered in patients with chronic or recurrent VLUs and in those with negative prognostic factors. Systemic agents may be used alone or in combination with compression and other mechanical modalities. Despite a number of studies designed to examine the efficacy and safety of adjunctive systemic therapy in patients with VLUs, and possibly as monotherapy, the cost-effectiveness of this approach has not been established. Pentoxifylline is an inhibitor of platelet aggregation which reduces blood viscosity and, in turn, improves microcirculation. The Cochrane Database reported an extensive review of randomized trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression in patients with VLU.⁴⁰ The authors found that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (RR, 1.70). Pentoxifylline plus compression proved more effective than placebo plus compression (RR, 1.56), and pentoxifylline in the absence of compression was more effective than placebo or no treatment (RR 2.25). More adverse effects were reported in patients receiving pentoxifylline (RR 1.56) and most of the reported adverse effects were gastrointestinal.⁴⁰   Like pentoxifylline therapy, aspirin (300 mg per day) combined with compression therapy has been shown to decrease ulcer healing time and reduce ulcer size compared with compression therapy alone.⁴¹ The therapeutic role of aspirin in VLUs is supported by observed increases in levels of fibrinogen, coagulation factor VIII, von Willebrand factor, and plasminogen activator inhibitor-1 in patients with VLUs compared with healthy controls.⁴² The addition of aspirin therapy to compression bandages may be useful in the treatment of VLUs as long as there are no contraindications to its use.   Bacterial colonization and superimposed bacterial infections are common in VLUs and contribute to poor wound healing. However, a recent Cochrane Review of 22 randomized control trials of systemic and topical antibiotics and antiseptics for VLU treatment found no evidence that routine use of oral antibiotics improves healing rates.⁴³ Oral antibiotics may be indicated in patients with VLUs and suspected cellulitis. Suspected osteomyelitis warrants an evaluation for arterial disease and consideration of intravenous antibiotics to treat the underlying infection. Only topical cadexomer iodine showed promising results.⁴³   Oxygen is essential to wound healing. Local tissue hypoxia, caused by disrupted or compromised vasculature, is a key factor that limits wound healing.⁴⁴ Clinical use of oxygen to promote wound healing began in the 1960s with the administration of systemic full body hyperbaric oxygen therapy (HBOT) to treat wounds.⁴⁵ Today, HBOT is usually administered in single- or multiplace chambers utilizing pressures of 2,500 mb and higher. There has been only 1 study on VLUs that indicated a significant reduction in wound area at 6 weeks following the administration of HBOT.⁴⁶ The problem with HBOT is the possible complications such as damage to the ears, sinuses, and lungs from the effects of pressure, temporary worsening of short-sightedness, claustrophobia, and oxygen poisoning. Although serious adverse events are rare, HBOT cannot be regarded as an entirely benign intervention. Furthermore, as an adjunct to standard therapy HBOT may be associated with increased costs, and any cost/benefit advantage should be carefully considered.⁴⁷

The “4-week” Model. The initial healing rate of VLUs and the percentage change in the ulcer area after treatment initiation have been shown to predict ulcer healing.⁴⁸ The use of a valid surrogate marker for complete VLU healing may allow for the identification of patients who are not likely to heal by standard methods early in the course of treatment, thereby allowing for expedited referral to specialty centers or the earlier initiation of advanced wound healing therapies.   The VLU treatment algorithm recommends > 40% wound closure after 4 weeks of conventional therapy as a surrogate marker for the identification of patients who are likely to achieve complete wound closure with continued conservative treatment. Patients with < 40% closure at 4 weeks are unlikely to achieve complete wound healing and may benefit from alternative or advanced interventions.⁴⁹   The algorithm recommendation is based on an analysis of wound characteristics and healing rates in 29,189 patients with 56,488 VLUs.⁴⁹ The median wound size was 189 mm² and the median wound duration was 3 months. By the 12th week of care, 45.2% of patients had healed. Those that healed had smaller wounds at baseline and wounds of shorter duration as compared with those that did not heal (all P values < 0.001). The continuous surrogates percent change in wound area, log healing rate, and log area ratio at weeks 2, 4, and 6 were shown to discriminate between a wound that healed by 12 weeks of care and one that did not. The 4-week surrogate maximized accuracy and minimized the time to surrogate endpoint. Dichotomization of the surrogate markers at week 4 demonstrated that a wound’s healing status at 24 weeks can be correctly classified at a rate of 66%-69% depending on the marker utilized. These surrogates were further validated by demonstrating that established risk factors for not healing, such as wound size and wound duration, are also important risk factors for not achieving the surrogate endpoint.   Skin autografts, allografts, and xenografts. A Cochrane Review was conducted to assess the effect of various skin grafts for treating VLUs.⁵⁰ The types of skin grafts examined in this review included autografts (from the patient’s own skin), fresh or frozen allografts (from other human sources), and xenografts (from pigs).   The review found that the randomized controlled trials were of generally poor methodological quality, characterized by flaws including lack of reported inclusion criteria, unclear descriptions of randomization methods, lack of baseline comparability, and lack of blinded outcome assessments. The authors concluded there was not enough evidence to recommend any of these types of grafts for the treatment of VLUs. It was recommended that further research be conducted to improve methods for identifying patients amenable to treatment with skin grafts and to assess whether skin grafts increase healing for VLU patients.   Bilayered and single-layered bioengineered cellular technologies. The Cochran Review of skin grafting for VLUs also examined the available evidence for bioengineered cellular technologies.⁵⁰ These advanced technologies feature living human cells and differ from traditional skin grafts in that they do not engraft or persist long-term, but instead delivery a cascade of growth factors and cytokines that stimulate healing in the recipient.   The single layer technology (Dermagraft, Shire Regenerative Medicine, Inc, San Diego, CA) contains only the dermal component and is comprised of human fibroblasts seeded onto a vicryl mesh. The Cochrane Review analyzed data from 2 single-layer technology VLU trials which employed different dosage regimes (1 piece, 4 pieces, and 12 pieces) and found there was no evidence of benefit associated with any of these dosage protocols.   The bilayered living cellular construct (Apligraf, Organogenesis, Inc, Canton, MA) contains 2 layers of living human cells—an epidermal layer of differentiated keratinocytes and a dermal layer of fibroblasts in a collagen matrix. The safety and efficacy of this bilayered living cellular product in treating VLUs was evaluated in a large prospective randomized controlled trial where patients were eligible to receive up to 5 applications.⁵¹ The results showed a significantly higher proportion of ulcers healed in the Apligraf treatment group, and also reported a shorter time to complete healing. Based on these findings, the authors of the Cochrane Review concluded that applying a bilayered living cellular construct with compression increases the chance of healing a venous ulcer compared to compression alone. Based on these Cochrane conclusions, the algorithm recommends applying bilayered living cellular constructs to VLUs that failed to reduce in size > 40% following 4 weeks of conventional care.   Surgical therapy. Direct surgical intervention may be helpful in patients with VLUs not responding to conservative management, but is generally performed to decrease the likelihood of VLU recurrence. In patients with first-time VLUs, healing rates with surgery are comparable to those achieved with conservative treatment. The benefits of surgical treatment may outweigh those of conservative treatment in patients with recurrent VLUs. Other factors favoring surgical intervention include medial ulceration, older age, and larger VLU size. Direct surgical intervention on the deep venous system is generally reserved for patients who do not respond to treatment of the superficial system or are not candidates for superficial venous intervention.   Surgical correction of superficial venous reflux does not increase healing rates in patients with VLUs receiving compression therapy. In 500 patients with open or recently healed VLUs and superficial venous reflux, healing rates at 3 years were 89% for the compression group and 93% for the compression plus surgery group (P = 0.73).⁵² Rates of ulcer recurrence at 4 years were 56% for the compression group and 31% for the compression plus surgery group (P < 0.01). Patients receiving compression plus surgery experienced significantly longer absolute (100 weeks vs 85 weeks, P = 0.013) and proportional (78% vs 71%, P = 0.007) ulcer-free time up to 3 years compared to those receiving compression alone. These findings support the role of surgery and compression therapy in patients with chronic wounds. Surgical correction of superficial venous reflux in addition to compression bandaging reduces the recurrence of VLUs at 4 years and results in a greater proportion of ulcer-free time.   Maintenance therapy. Appropriate maintenance therapy following healing of VLUs may help prevent the occurrence of new VLUs and reduce the incidence of ulcer recurrence. Well-designed randomized controlled trials of maintenance strategies following VLU healing are rare. Maintenance treatment with compressive stockings and appropriate skin care should be considered in all patients with healed VLUs. The identification of patients who are likely to benefit from posthealing VLU surgery is difficult. It is unclear which type of compression stocking may be most suitable for maintenance therapy, and the choice may be based on cost issues and patient and provider preferences. Further studies, including economic evaluations, are needed to help determine the optimal maintenance strategies in patients with VLUs.   Functional restoration. Patients with VLUs experience significant functional impairment including loss of mobility, decreased work capacity, limitations in leisure activities, and challenges with activities of daily living. In addition to ulcer healing and prevention of recurrence, functional restoration, defined as a return to pre-VLU levels of activity, may be an appropriate endpoint in VLU clinical trials and a useful marker of VLU treatment success. From the patient’s perspective, pain relief and restoration of functional capacity may be the most important outcomes of VLU treatment. Providers should monitor changes in functional capacity during VLU treatment and consider lack of functional restoration as a possible marker of inadequate treatment.

This paper describes an evidence-based algorithm for the treatment of VLUs. The algorithm is based on current and unbiased analysis of randomized clinical trials. Widespread implementation of the VLU treatment algorithm has the potential to improve outcomes, restore function, and reduce costs associated with VLU.

Poster presented at: The National 2012 American Podiatric Medical Association Annual Scientific Meeting; August 16-19, 2012; Washington DC.

Howard M. Kimmel, DPM, MBA, FACFAS is from Louis Stokes Cleveland VA Medical Center, Cleveland, OH; and Case Western Reserve University School of Medicine, Cleveland, OH. Angela L. Robin, DPM is from Louis Stokes Cleveland VA Medical Center, Cleveland, OH; 2Case Western Reserve University School of Medicine, Cleveland, OH.

Address correspondence to: Howard M. Kimmel, DPM, MBA, FACFAS Louis Stokes Cleveland VA Medical Center 10701 East Boulevard Cleveland, OH buckeyefootcare@sbcglobal.net

Disclosure: The authors disclose no financial or other conflicts of interest.