Management and Prevention of Venous Leg Ulcers: A LiteratureGuided Approach

Brian T. Kunimoto, MD
ABSTRACT Managing venous leg ulcers involves management techniques that are indicated both in the treatment of all chronic leg ulcers and those that are specific to venous leg ulcers. The first step in managing venous leg ulcers is performing a holistic assessment of the patient. Once this is complete, any systemic or local factors that may affect wound healing should be addressed. This approach to managing the whole patient is critically important because if significant general wound healing factors are not treated, other specific attempts at healing the venous ulcer will be fruitless. This paper reviews nutritional supplementation, wound bed preparation, antimicrobial therapy, venous insufficiency, compression therapy, different bandage systems, therapeutic adjuncts to compression therapy, and recent advances in vascular surgery. Recurrence prevention also is discussed. Ostomy/Wound Management 2001;47(6):3649

aspects of holistic care must be considered. All too often, these important issues are ignored, as caregivers tend to focus only on treating the ulcer. For example, systemic factors that may inhibit wound healing must be corrected or the ulcer will not heal. Additionally, the milieu of the wound bed must be optimized and debridement may be necessary. If the bacterial load is thought to be a significant problem, antibiotic therapy may be required. Furthermore, the principle of moist wound healing must be applied in the selection of ulcer dressings. This paper reviews the above as well as the principles of medical and surgical management of venous disease and adjunctive medical and surgical therapy.

General Management of Venous Leg Ulcers

Treating the whole patient. After careful holistic assessment, all patients with suspected malnourishment should be assessed by a nutritionist or dietitian. Protein and vitamin deficiencies are not uncommon, particularly in the elderly. Identifying and treating protein malnutrition is the most important aspect of nutritional therapy. Managing these deficiencies may make the difference between a healing and a nonhealing wound even in the presence of best ulcer care. Protein replacement, when deficiency exists, has been shown to be beneficial. In the animal model, in the presence of protein malnutrition, parenteral nutrition has

ecause the population is aging and venous leg ulcers are common in the elderly,1 wound care providers must have the skills to diagnose and manage venous leg ulcers. Wound healing in general must first be optimized both in terms of the whole patient and in terms of the wound itself. Only after such issues are identified and treated can specific therapy be directed at venous disease. In preparing the patient for successful healing, several

Dr. Kunimoto is Clinical Assistant Professor, Division of Dermatology, Department of Medicine, The University of British Columbia, Vancouver, British Columbia. Address correspondence to: Brian T. Kunimoto, MD, Division of Dermatology, Department of Medicine, The University of British Columbia, 835 West 10th Avenue, Vancouver, British Columbia, V5Z 4E8, Canada.

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been demonstrated to improve fibroblast activity.2 Similarly, in malnourished humans, collagen synthesis has been shown to be improved by enteral nutrition in the immediate postoperative period.3 It also restores malnutrition-induced impairment of immune responses.4 Vitamin A. Although, in one study, vitamin A supplementation in nondeficient animals and humans was found to be beneficial,5 its use should be confined to patients who are deficient. Theoretically, vitamin A may benefit patients who are taking large doses of glucocorticosteroids6; however, high doses of vitamin A may be required, which may be unsafe. In this situation, the deleterious effects of high doses of glucocorticosteroids may be reversed by the vitamin A supplementation. More clinical study is needed before the use of vitamin A for this particular indication can be recommended. Vitamin A should be administered with caution because high doses (more than 50,000 IU/day) can be associated with hypervitaminosis A syndrome. Routine use of vitamin A supplementation in the management of venous ulceration is not recommended. It should be used only in patients who are vitamin A deficient. Vitamin C. In the presence of vitamin C deficiency, wound healing is significantly impaired in terms of speed and tensile strength.7,8 In patients suffering from vitamin C deficiency, supplementation is reasonable. The recommended daily allowance for ascorbic acid is 60 mg.9 In major burn injuries, up to 2 g per day may be required to restore adequate tissue levels.10 There is no evidence that even higher doses of vitamin C may be toxic making supplementation relatively safe.11 Few studies have examined vitamin C supplementation in nondeficiency states. No evidence shows that large doses of vitamin C benefits human wound healing unless a deficiency exists.12 One randomized double-blind trial examined 88 patients with pressure ulcers and found no significant benefit for healing when vitamin C was given as an adjunct compared to placebo.13 On the other hand, in severe acute wounds, such as large burns, body stores of vitamin C may be rapidly depleted, making routine supplementation with large doses appropriate.12 The routine use of vitamin C supplementation in the management of venous ulceration is not supported by the literature. Its use should be restricted to patients who are deficient. Vitamin E. The use of vitamin E in wound healing is controversial. Animal studies have shown some benefit in

the healing of rat gingiva14 and myocardium in dogs.15 One uncontrolled human study showed that vitamin E appeared to accelerate healing in venous leg ulceration.16 A recent literature review of the possible uses of topical and systemic tocopherols in dermatology revealed only weak and conflicting evidence that vitamin E is of value in the management of leg ulcers and wound healing in general.17 Little or no evidence supports the use of vitamin E in chronic wounds despite its popularity in the lay community. Controlled studies are needed. Zinc. Traditionally, zinc supplementation has been considered to be a useful adjunct to wound management. Although zinc deficiency, which is quite uncommon, is associated with delayed wound healing18 and reduced tensile strength,19 no study has shown that zinc supplementation in nondeficiency states benefits wound healing.20 A more recent review of the literature as of 1998 could not identify a clinical trial that showed a statistically significant benefit of zinc sulfate for healing venous or arterial leg ulcers.21 Zinc supplementation is indicated when deficiency exists. Arterial insufficiency. If the leg affected by the venous leg ulcer is complicated by significant arterial insufficiency, consultation with a vascular surgeon is recommended. Any wound, acute or chronic, affected by ischemia as a result of severe arterial insufficiency, will not heal no matter what local measures are employed. If the arterial disease is considered uncorrectable or if the patients general health precludes surgery, management becomes palliative and expectations of healing should be abandoned. Wound bed preparation. Wound bed preparation requires management in three areas: debridement (if significant wound debris, including slough, eschar, and crust, is present); antimicrobial therapy (if bacteria in the
Ostomy/Wound Management 2001;47(6):3649

KEY POINTS
t
In this second of two review articles (see Ostomy/Wound Management, 2001;47(5):3853, the author reviews the research base of all commonly used ulcer management and prevention strategies. In addition to providing a succinct guideline for care, the author identifies several areas in need of additional research, including guidelines for wound cultures and antibiotic treatment and the comparative efficacy of different types of compression bandages.

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TABLE 1 ADVANTAGES AND DISADVANTAGES OF DEBRIDEMENT25

Method Autolytic (Moist occlusive dressings) Advantages Easy to use Utilizes moist occlusion Painless Effective when minimal debris present Easy to apply Painless May be combined with surgical debridement Easy to perform Disadvantages Slow method (may require weeks)

Chemical (Enzymatic) Mechanical (Hydrotherapy, wetto-dry dressings, irrigation, dextranomer) Surgical (Sharp debridement)

May irritate surrounding skin May be slow if slough or eschar is thick May be expensive Requires equipment (hydrotherapy, irrigation) May remove viable tissue especially with wet-to-dry dressings Painful

Biological (Maggots)

Immediate results Can be used with local anesthesia Any debris may be debrided Very selective

Requires training May be painful and may need anesthesia

Maggots must be cultured and ordered

ulcer base exists); and dressings (to achieve the optimum moist wound healing environment). Debridement. When slough and wound debris obscure the base of the ulcer, debridement becomes essential.2224 Necrotic tissue left in the ulcer contributes to reduced host resistance to infection because it acts like a foreign body. Dead cells also release substances that inhibit healing. However, debridement is contraindicated in ulcers when healing is complicated by severe arterial insufficiency. The many ways to debride a wound (see Table 1) are well covered in an excellent recent review article.25 Venous leg ulcers often have fibrin in the base, which appears as a dark yellow to brown gel and is easily dislodged by gentle swabbing with a cotton tip applicator. Alternatively, autolytic debridement easily and painlessly can clear this fibrinous material. In general, ulcers complicated by significant arterial ischemia have slough and, sometimes, dry eschar in the base as opposed to typical venous leg ulcers. Antimicrobial therapy. If the bacterial load in the ulcer is suspected of being sufficient to impair wound healing, antimicrobial therapy must be considered.

Bacteria can potentially become successful competitors for the natural resources for wound healing. If a sufficiently large population of a pathogenic species of bacteria is multiplying in the living tissue of the ulcer, healing will be severely impaired. However, bacterial quantitation may not tell the whole story. Bacterial virulence that varies among different bacterial species in the wound also will impair healing. Lastly, if host resistance is deficient, bacteria will thrive and markedly impair the healing process. Host resistance comprises systemic and local factors. Systemic factors include immune defenses and wound vascularity. Many systemic conditions such as diabetes and malnutrition contribute to reduced immune responses. Some examples of local factors include necrotic debris and foreign bodies that may be present at the wound surface. The combination of these three factors determines the risk of significant bacterial influence on healing. If this bacterial influence is considered sufficient to abolish good healing, antimicrobial intervention is necessary. The decision to use antibiotics for clinically infected ulcers is an easy one. The patient who develops periulcer erythema, swelling, cellulitis, purulence, tenderness and

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pain, and sometimes fever and toxicity, is a good candidate for systemic antibiotic therapy. In this situation, taking a culture swab of the wound base after cleansing and debriding taking care not to sample the normal flora of the wound edge is justified. Although the patient will likely be started on an antibiotic before results are available, changes can be made later if sensitivity results are not favorable and the wound is not responding. Careful interpretation of culture results is necessary because multiple organisms frequently are identified. Determining which of the bacteria is the pathogen is difficult.26 Also, caution must be exercised in interpreting laboratory attempts to quantify the results. Further research is needed to correlate swab techniques and quantitative results with healing rates. Large studies have not been published to verify correlation between swab sampling and quantitative biopsy.26 Infection is only one cause of periulcer inflammation; therefore, cellulitis must be differentiated from these other causes. Venous dermatitis (stasis dermatitis is a misnomer) occurs much more frequently than wound infection and is also more common in the summer months. This form of eczema presents with erythema, scaling, erosion, and excoriation. Deep swelling characteristic of cellulitis is not seen. Another noninfective cause of periulcer eczema is the irritant dermatitis that occurs under the wound dressing if excessive moisture is draining from the ulcer. Wound fluid contains many proteolytic enzymes that can be very irritating to the surrounding skin. Again, deep swelling is absent. One other cause of peri-ulcer eczema is allergic contact dermatitis. Once a venous leg ulcer is considered clinically infected, systemic antibiotic therapy is indicated. In most cases oral antibiotic therapy is adequate. The use of topical antibiotics in this situation is not established as standard therapy,26 and although common in practice, remains to be clarified by clinical study. In cases where the infection is thought to have resulted in septicemia, intravenous therapy is necessary. The choice of antibiotic is most often empirical and occurs before the bacterial species is identified. In the case of venous leg ulcers, Gram-negative organisms are common colonizers, although, in general, chronic ulcers of less than 1-month duration are usually colonized by Gram-positive organisms.27 Staphylococcus aureus and Group A Streptococcus are important to consider. In these settings, cephalexin would be an ideal choice,

although cloxacillin is often used as well. If moist, occlusive wound dressings are used, the bacterial flora gradually changes to favor Gram-negative and anaerobic organisms.28 After 1 month of therapy, the empirical choice of antibiotic therapy must accommodate these changes. For milder infections, clindamycin and cotrimoxazole would be a good combination.26 More severe, potentially lifethreatening infections may require intravenous clindamycin and a third-generation cephalosporin agent such as cefotaxime.26 Distinguishing the rapidly healing wound from the clinically infected one is not difficult. However, between these two extremes lies a gray area where the wound stops healing because of significant bacterial numbers, but as yet shows no obvious signs of inflammation. In these cases, despite optimal management of venous insufficiency, using appropriate dressings, and debridement, the wound will show no improvement for several weeks. Furthermore, wound deterioration may be noted as healthy-looking granulation tissue turns into dusky, dark red, friable tissue or is replaced by yellow necrotic slough. In both of these situations, the signs and symptoms of infection may be absent. The existence of this gray area between noninfection and clinical infection needs to be clarified, possibly by developing diagnostic criteria. In this situation, considering an empirical trial of oral antibiotics is justified in the authors opinion. However, prospective studies are needed to confirm this approach. The role of nonantibiotic antimicrobials such as cadexomer iodine and silver-coated membranes in this situation also remains to be defined. Wound bacterial culturing. The routine use of wound bacterial culturing should be discouraged. Sampling of the wound for bacteria should be reserved for instances when nonhealing or deterioration of the wound is considered to be due to bacterial influence. The only reason to take a swab of a wound for bacteria is to obtain information to make the antibiotic decision-making process more accurate. Patients often are managed with antibiotics as adjunctive therapy even though significant infection is not suspected. In many cases, antibiotics are prescribed on the basis of a positive culture swab result. However, the literature does not support this approach. One randomized, controlled trial compared the use of elastic support bandages to the same treatment plus systemic antibiotics.29 No significant differences were noted in terms of healing rates or changes

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should be utilized whenever possible. TABLE 2 Moist wound healing. CLASSIFICATION OF WOUND DRESSINGS In 1958, Odland demonDressing Type Main Uses Contraindications strated that blister Plastic films Epithelialization Draining wounds wounds healed faster if Infected ulcers left intact.34 Then in the Poorly granulated ulcers early 1960s, a study Hydrocolloid dressings Granulation tissue formation Infected wounds reported that occluded Excessively draining ulcers porcine wounds healed Absorbent dressings Absorption of exudate Superficial wounds faster than dry ones.35 At Infected wounds Epithelializing wounds Calcium alginates Absorption of exudate Superficial wounds that time, the concept of Hemostasis Epithelializing wounds moist wound healing Infected wounds originated. Over the last Hydrogels Hydration of dry wounds Infected wounds 20 years, an explosion in Donor sites (grafts) Excessively draining ulcers the number of new dress Epithelialization ings that incorporate the Biological dressings Difficult cases Infected ulcers advantages of moist occlusion has occurred. Moisture is required for the survival of cells involved in in bacterial flora. The routine use of systemic antibiotics healing and preserves the activity of growth factors and is ineffective, costly, and will only facilitate the emerenzymes important in the wound healing process. Many gence of yet more drug-resistant bacteria. of these enzymes are proteolytic and are important in the Topical antibiotics. The use of topical antibiotics as process of autolytic debridement. Occlusive dressings also routine adjuncts to venous ulcer therapy should be disprovide a physical barrier to invasion by bacteria from couraged.26,30 Further research is needed to conclusively the surrounding skin. This is likely the reason infection define the use of topical antibiotics in wound healing. rates are lower for occlusive dressings when compared to Evidence is lacking that shows that topical antibiotics are nonocclusive dry dressings.36 In fact, the use of hydrocolcapable of eliminating bacterial colonization. loid dressings is associated with the lowest infection rates Concentrating on proper wound bed preparation to of 1.3% compared to 7.6% for dry dressings.35 In addireduce bacterial burden and improve host resistance tion, re-epithelialization rates are also increased by 30% would be far more effective. to 50% under moist occlusion.35 An exhaustive review of Topical agents. Avoiding the use of potentially allergenic materials is important. Contact eczema is always a wound dressings is covered in three excellent current risk when patients or caregivers use a multitude of topical reviews3739 (see Table 2). agents in chronic wound healing. Evidence demonstrates With respect to venous leg ulcers, specific issues must that, on the legs, patients with venous insufficiency are be addressed. For example, an edematous leg ulcer will more susceptible to allergic contact dermatitis from topiproduce a great deal of drainage, which can be copious 3133 30 cal agents. for the first few weeks of treatment. This means that the One study showed that 50% of leg ulcer initial wound dressing should have considerable patients demonstrated allergic contact sensitization in the absorbency. Also, during this early stage of ulcer manageabsence of concomitant or past history of eczema. For ment, the absorbent dressing may have to be changed these reasons, topical agents containing such substances frequently to avoid the development of irritant dermatitis as neomycin and related antibiotics, fragrance, lanolin, of the surrounding skin. This also reduces the annoying and preservatives such as benzalkonium chloride and 32 odor that accompanies treatment, particularly with parabens should be avoided. hydrocolloid dressings. Appropriate dressing types for Dressings. Chronic ulcer management requires the this situation include absorbent foam dressings and calciuse of wound dressings that provide the optimal moist um alginates. environment for healing. Moist occlusive dressings

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Once the initial edema is under control, switching to a hydrocolloid Compression = N (number of bandage layers) x T (bandage tension) dressing that still retains some R (radius of the leg) absorbency is often useful. This Figure 1 dressing can potentially be left on for Law of Laplace (modified). up to 1 week and may be combined Regarding venous leg ulcers and dressings, the author with compression bandaging. believes that a wound covered by new epidermis should be After the granulation tissue has filled the defect, faciliprotected for about 2 months because the new skin covertating re-epithelialization is important. At this time, ing the wound is fragile. In fact, the process of matrixdressing changes should be kept to a minimum, as kerremodeling continues for several months after the ulcer has atinocytes beginning to migrate across the wound do not grown skin cover. Any protective dressing may be used for anchor to the wound bed until it is covered. Too frequent this purpose. Thin hydrocolloid dressings are a good dressing changes at this point tend to tear off the neoepchoice because they can be applied under elastic stockings. ithelium before it has a chance to establish itself. Fenestrated, nonadherent plastic film dressings may be best at this stage of healing. Specific Venous Ulcer Management One interesting recent advance in managing venous leg Compression therapy. The cornerstone of managing ulcers has been the development of biological skin equivavenous leg ulcers is treating the underlying disease: lents. In 1997, a cultured, allogeneic, bilayered human Venous insufficiency. In the vast majority of patients, this skin equivalent, Apligraf (Organogenesis, Canton, Mass.; involves some form of compression therapy. Novartis Pharmaceuticals Canada Inc., Dorval, Quebec, Venous hypertension underlies the development of Canada), was first released in Canada. This has made venous ulceration. In a way, the venous leg ulcer is simtreating nonhealing venous and other difficult-to-treat ply a complication of this underlying disease. The final 40 ulcers possible. By 1999, considerable Canadian experiinsult to the skin before the development of the ulcer is cutaneous ischemia as a result of the venous disease. ence had accumulated resulting in a consensus paper,39 Without correction of the underlying disease, this which recommended that healthcare providers consider ischemia persists, resulting in a chronic wound that will using the human skin equivalent if the venous ulcer does not respond to general measures. Compression therapy not show significant healing after 1 month of optimal with a number of different bandaging systems corrects therapy. The pivotal study that confirmed the efficacy of this problem, giving the ulcer a chance to heal using the the human skin equivalent, Apligraf , was a randomized, proper techniques of wound bed preparation. multicentered, prospective study involving 275 patients 41 All ambulatory patients with venous leg ulcers require with venous leg ulcers. The researchers found that treatcompression therapy. A recent systematic review of the ment with human skin equivalent was more effective than literature was conducted restricting the search to rancompression therapy alone in the percentage of patients domized controlled trials.42 The authors concluded that healed at 6 months (63% vs 49%). Also, the median time to complete wound closure was 61 days for the human compression systems improve the healing of venous leg skin equivalent group compared to 181 days for those ulcers and should be used routinely in uncomplicated receiving compression therapy alone. Both results were venous ulcers. Many caregivers are unaware of this fact considered statistically significant. Although this dressing and rely on topical treatments such as creams and the latis expensive and must be delivered by courier for use est wound dressings.43 Part of the reason for this may be within a short time, human skin equivalent may provide that only over the past decade has the mechanism of how an alternative treatment for nonhealing wounds. external compression works been elucidated. Many careIn the past decade, a great deal of research also has givers are faced with a confusing array of different combeen conducted in the field of growth factors. However, pression bandage systems, making treatment decisions the use of growth factors has been more successful in unnecessarily difficult. treating diabetic and pressure ulcers than in the treatCompression pressures. Compression pressures of at least ment of venous leg ulcers. 30 mm Hg to 40 mm Hg at the ankle should be utilized

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in the management of venous leg ulcers. All compression bandage systems must create a pressure gradient from ankle to knee. According to the Law of Laplace (see Figure 1), which mathematically relates bandage tension, compression pressure, and limb girth, the shape of the leg will create this gradient. Thus, if the bandage tension is constant as the healthcare provider winds the bandage up the leg, a compression gradient will naturally develop because the smallest limb radius is found at the level of the gaiter area, just proximal to the ankle joint. As the bandage is wrapped up the leg, progressively larger radii are encountered, resulting in lesser degrees of compression given the constant bandage tension. This pressure gradient provides support against venous hypertension, which is greatest at the ankles when the patient is standing. Correcting venous hypertension requires that the compression system be capable of exerting at least 30 mm Hg of pressure at the level of the ankle.4446 One study44 demonstrated that after 15 minutes of motionless standing, the transcutaneous oxygen tension around the ankle drops to very low values. After examining the effects of different degrees of compression using a pneumatic pump device, the researchers found that 30 mm Hg to 40 mm Hg at the ankle area abolished this response. The occasional venous ulcer patient is nonambulatory or absolutely cannot or will not tolerate compression therapy. Most experts recommend these patients utilize leg elevation (at least 2 hours per day) as an alternative. This requires positioning the ankle at the level of the heart. Sometimes this can be achieved by placing 6-inch wooden blocks under the foot of the bed. Asking the patient to keep a legs-up chart can benefit compliance. Compression systems may be classified into three groups: short-stretch bandages (SSB), long-stretch bandages (LSB), and stockings. If the limb affected by the ulcer is edematous, most experts recommend using an SSB system.45,47,48 Because SSB, by definition, provides little or no elasticity against the contracting calf muscle, the highest working pressures are attained. This working pressure drives blood in the deep femoral vein upward. For the same reason, when the calf muscle relaxes, the bandage does not continue to exert pressure. This low resting pressure facilitates deep venous filling.45 Short-stretch bandage systems require patients to be ambulatory. Without a calf muscle capable of contracting, the inelastic bandage becomes ineffective. Thus, patients who tend to shuffle around need to be trained to

walk properly, making sure they push off with their toes. Similarly, those patients with ankle joints stiffened by arthritis or old injury may not be good candidates for SSB systems. Despite expert opinion that supports the use of SSB while managing edema, only a few studies compare them to LSB and the results have been far from conclusive. One recent controlled, nonrandomized study found that inelastic compression was better than elastic compression for reducing deep venous reflux.49 Another study, which looked at venous pressure in the dorsal vein of the foot during treadmill walking, found that only the shortstretch system was able to reduce the elevated venous pressure seen in venous insufficiency.50 One recent prospective, randomized, observer-blind, parallel group study compared both systems in 32 patients with 39 ulcers. After 15 weeks, using complete healing as the endpoint, the study found no statistically significant difference.51 A prospective, randomized trial comparing the four-layer bandage system with an inelastic bandage in 53 patients revealed no significant differences in healing after 12 weeks.52 Other comparison trials are currently under way. Long-stretch bandages are more commonly used than SSB systems in North America and the United Kingdom. The four-layer bandage is popular because it is capable of maintaining high compression for several days and up to a week. This reduces the frequency of dressing changes, a great advantage for home healthcare nursing. The fourlayer bandage must be applied by trained personnel. Because of elasticity, the four-layer bandage and other LSBs continue to exert compression even when the leg is elevated. This can be a problem if the patient has significant arterial insufficiency. Therefore, the four-layer bandage should not be used in patients with an anklebrachial index (ABI) of less than 0.8. Other LSB systems are capable of lower levels of compression. These systems are relatively safe in the presence of moderate arterial insufficiency. They may be used if the ABI is greater than 0.5 and require only a minor degree of training. Like the four-layer bandage, they may be left on for 1 week at a time. In the presence of severe arterial disease (ABI less than 0.5), even these lower compression systems are contraindicated. Surgery. In some cases, the wound stubbornly refuses to heal even after systemic factors have been managed, the wound bed has been optimized, and compression

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therapy has been instituted. In this situation, venous vascular surgery should be considered. Venous incompetence in the deep system cannot be corrected surgically. On the other hand, perforator incompetence and disease of the superficial venous system can be managed using new surgical techniques that are associated with only mild morbidity. Significant perforator incompetence may cause localized venous hypertension that may not be adequately managed by the use of a compression bandage system. Chronic venous insufficiency is caused by vascular disease affecting the deep, perforator, or superficial veins. Historically, the first theories on venous insufficiency postulated that the primary problem with the postthrombotic leg was that of deep-vein obstruction. Obstruction of the deep veins was thought to cause venous hypertension. Later, a small minority of patients was found to have isolated venous outflow obstruction, and in 90% to 95% of cases, valvular incompetence is the cause of venous hypertension.53 Deep vein valvular incompetence is believed to be of greatest importance in pathogenesis. Despite Hippocrates observation correlating leg ulceration with the presence of varicose veins, superficial venous disease has been considered to be much less significant. Recently, duplex ultrasound scanning has improved the measurement of reflux in deep, superficial, and perforator veins. Of interest is the finding that a lesser but significant proportion of venous ulcer patients has competent deep veins and isolated superficial venous reflux.54 Many of these patients have isolated incompetence of great or lesser saphenous veins and may benefit from saphenectomy. In patients with combined deep and superficial disease, the removal of varicose superficial veins has been feared to eliminate an important venous outflow tract for occluded or hypertensive deep veins. This may not be true in the majority of cases. One study found that less than 10% of patients with deep vein obstruction had significant reduction of venous outflow when the superficial veins were occluded.55 A recent study demonstrated that in patients with combined disease, ablation of superficial and perforator veins reduced deep venous reflux.56 Another study showed that preoperative femoral vein reflux could be abolished by greater saphenous vein stripping in 27 of 29 limbs.57 Although more research is needed, lesser saphenous vein reflux might be a significant contributor to venous ulceration. One recent study

showed that incompetence of the lesser saphenous vein may contribute to venous insufficiency and ulcers of the lateral aspect of the leg.58 However, a significant proportion of these patients have associated deep venous incompetence, making lesser saphenous vein ablation ineffective in improving long-term outcome.53 The role of perforator vein incompetence in chronic venous insufficiency requires more study as well. Perforator vein incompetence is accepted as important in the development of venous ulcers. In 1949, Linton described a technique for dissecting incompetent perforators using a long paratibial incision.59 This procedure causes significant morbidity and prolonged hospitalization. Since the mid-1990s, subfascial endoscopic perforator surgery (SEPS) has been studied.60 Its major advantage over the Linton procedure is the greatly reduced postoperative morbidity. One study examined the use of SEPS in 19 patients with venous ulcers.61 The ulcers had been present an average of 4.4 years. After treatment, all ulcers healed within 90 days. A more recent study from the Mayo Clinic reported an ulcer recurrence rate of 12% after SEPS compared to their population average of 28%.62 Contrasting these good results, another study reported failure of healing or ulcer recurrence after SEPS ranging from 2.5% to 22%.63 This study stated that one limitation of SEPS is that perimalleolar perforators are difficult to access. Currently, surgical ablation of incompetent superficial veins and SEPS cannot be recommended as routine procedures. Certainly, if an ulcer shows no sign of healing after 3 months using best practices, vascular surgery should be considered. However, more research is needed over the next few years to establish the role of vein surgery in the treatment of nonhealing venous leg ulcers.

Adjunctive Therapy
Physical therapy for the ankle joint. A physical therapist should be consulted for patients who possess little ankle mobility if any potential for improvement of joint flexion and extension exists. The ankle joint is equivalent to the hinge component of the calf muscle pump. A mobile ankle joint is essential for the pump to function. If the joint in a patient with chronic venous insufficiency is ankylosed, venous congestion is exacerbated. Patients with this problem tend to shuffle around, barely lifting their feet off the floor. Furthermore, the ability of compression bandages such as the SSB system to enhance

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venous return is compromised in the presence of the frozen ankle. Chronic venous insufficiency itself may contribute to ankle immobility through the deposition of fibrotic tissue. If ankle joint mobility is present, and an SSB system is being used, the patient should be encouraged to raise both heels off the ground while in a standing position. The shuffling gait that is so common among the elderly should be discouraged. If joint mobility is reduced, yet potential for improvement exists, a physical therapist may be able to loosen soft-tissue contractures through the use of physiotherapy. Intermittent pneumatic compression. One means of intermittently increasing compression to relieve edema is to use the intermittent pneumatic compression (IPC) device. Because some patients require higher levels of compression than is tolerated, noncompliance with the bandage system becomes an issue. The IPC device can be used as an adjunct to compression bandaging. It also may be used as an alternative to compression bandaging in patients who are relatively immobile and, therefore, unable to activate the calf muscle pump. The IPC device comprises a series of balloons that are inflated by a pump. The timing of balloon inflation in sequence moves edema fluid toward the inguinal region. This device may be used to quickly reduce the volume of the leg before compression bandages or graduated compression stockings are applied. The device is also useful as an alternative to compression bandages in patients who lack good mobility and cannot walk around to activate the calf muscle pump and in those with lymphedema. IPC therapy is contraindicated in the presence of significant arterial insufficiency, and edema due to congestive heart failure. One randomized, controlled study compared healing rates for 24 patients using moist occlusive dressings and graduated compression stockings (30 mm Hg to 40 mm Hg) with 21 patients using the same treatment plus IPC for a total of 4 hours per day. The treatment period lasted 3 months. Only one patient in the control group completely healed compared to 10 of the 21 in the IPC group (P = 0.009, Fischers exact probability test).64 Another randomized, prospective controlled study examined 22 patients. Both groups received local wound care and Unnas boot. The experimental group used IPC twice weekly for 1 hour each session and achieved statistically significant better healing rates.65

Intermittent pneumatic compression may be a useful adjunct that complements compression bandage or stocking therapy in the treatment of venous leg ulcers and may be used in difficult cases.66 Medication therapy: Edema-preventive drugs. Lymphedema may result in patients who have longstanding venous edema. This type of edema may respond to coumarin drugs, which may be recommended as adjunct therapy. The benzopyrones (coumarin) have been shown to be efficacious in the management of chronic lymphedema.67 Long-standing venous hypertension often develops into chronic lymphatic insufficiency, especially in obese patients. Diuretics should not be used in the management of edema caused by venous insufficiency. The edema associated with venous disease is caused by pump failure, which causes venous hypertension and leakage of fluid from the intravascular compartment into the interstitial space. None of this can be corrected with diuretics. However, diuretics may be required during edema management using compression bandaging in patients who suffer from congestive left-sided heart failure. Here, significant increases in effective arterial blood volume may be evident; these are caused by the improvement in calf muscle pump function afforded by bandaging. This sudden shift of fluid from the interstitial space into the blood may exacerbate left ventricular function, resulting in the appearance of pulmonary edema. This should be a consideration in the elderly with fragile cardiac function. Hemorheologic agents. The routine use of hemorheologic agents, such as pentoxifylline, in the treatment of venous leg ulcers is not recommended at this time. Pentoxifylline increases the deformability of red blood cells, improving blood supply to ischemic tissues. It also has been found to reduce white blood cell trapping, making it an attractive therapeutic agent in venous ulcer management.68 A review of the literature does not unequivocally endorse the use of pentoxifylline. One of the original studies was a prospective, randomized, double-blind, placebo-controlled trial involving 80 consecutive venous leg ulcer patients for 6 months.69 Complete healing was seen in the pentoxifylline group in 23 of 38 patients, compared to 12 of 42 patients in the placebo group. This was found to be statistically significant. A more recent double blind, placebo-controlled trial involved only 12 patients.70 Drug or placebo was administered for 60 days. In the active drug group, complete

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healing was seen in 4 of 6 patients compared to 1 of 6 in the placebo group. This was considered statistically significant; however, the study size was small. The most recent randomized double blind, placebo-controlled trial involved 200 patients.71 Complete healing was seen in 65 of 101 (64%) patients receiving active drug compared to 52 of 99 (53%) patients on placebo drug. This result did not reach statistical significance. Management of obesity. In many patients with venous ulceration, morbid obesity is a problem that must be managed concomitantly with specific venous ulcer therapy. Morbid obesity directly causes deep venous insufficiency. If obesity is not managed, it is the authors opinion that compression therapy will be difficult if not impossible. Morbidly obese patients usually do not tolerate compression therapy. Obesity is a risk factor for the development of venous hypertension. Patients who are severely obese may not be able to lie down in bed at night as a result of restrictive respiratory failure. However, sleeping in a chair can have disastrous consequences on venous hypertension. Lymphatic insufficiency is not unusual among these patients and ulceration presents a major therapeutic challenge. After venous ulcer healing, continued morbid obesity will predispose patients to ulcer recurrence. Obesity management requires the skills of a dietitian or weightloss expert.

Prevention of Venous Leg Ulcers

Graduated compression stockings. Once the venous leg ulcer has healed, prevention must be the main objective. In all ambulatory patients, graduated compression stockings (GCS) should be recommended. Graduated compression stockings are of proven value in the management of venous hypertension.7274 The issue of ulcer prevention was illustrated in a study that examined ulcer recurrence rates both with and without the regular use of GCS rated at 30 mm Hg to 40 mm Hg.75 Fifty-three patients with venous leg ulcers were healed using GCS. They were followed for the next 6 months and compliance with stocking use was evaluated. Among the 25 patients who demonstrated good compliance, one ulcer recurred. Of the 28 patients who were either poorly or noncompliant, 22 had at least one ulcer recurrence. One 15-year retrospective study examined the efficacy of GCS in the management of venous ulcers.76 Of 113 patients, 105 (93%) achieved 100% healing after an average of 5.3

months. One hundred two patients were compliant in the use of GCS and 11 patients were not. Of those who were compliant, 99 of 102 (97%) patients healed compared to 6 of 11 (55%) patients who were not (P < 0.0001). Several variables were examined for predictiveness of outcome and only noncompliance with GCS (P < 0.0001) and pretreatment ulcer duration over 9 months (P = 0.02) were found to significantly decrease healing. Post-healing follow-up was available for 73 patients for a mean of 30 months. Fifty-eight patients continued to use stockings regularly; 15 patients did not. Ulcer recurrence was seen in 16% of patients who were compliant. All patients who did not wear GCS regularly experienced ulcer recurrences. Most experts in the field agree that a compression level of 30 mm Hg to 40 mm Hg is ideal for venous insufficiency. Some patients cannot tolerate this level of compression and may require lighter stockings.77 No literature evidence suggests that stockings need to extend higher than the knee. Patient compliance with the use of GCS is a major issue. Patients should be told that stockings must be applied first thing in the morning and removed in the evening. Several mechanical devices are available that facilitate the application of the garments even if a small ulcer is present. These devices can aid patients who suffer from arthritis of the hands or poor flexibility of major joints. Most stockings have a usable life of about 6 months. Adequate compression beyond this time cannot be guaranteed. The cost of the stockings to the patient should be justified as they offset the greater costs associated with managing recurrences. Surgery. As vein surgery may be useful in the management of select cases of stubborn venous ulceration, it also may be considered for ulcer prevention and in ulcers not responding to adequate compression therapy. After ulcer healing, if significant superficial and/or perforator vein incompetence exists, surgical ablation/ligation should be considered as part of overall preventive care.78 - OWM

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