Wound, Pressure Ulcer, and Burn Guidelines-5: Guidelines for the management of lower leg ulcers and varicose veins, second edition

1 BACKGROUND TO THE DRAFTING OF THE GUIDELINES FOR THE MANAGEMENT OF LOWER LEG ULCERS AND VARICOSE VEINS

Guidelines are “documents systematically prepared to help medical specialists and patients to make appropriate judgments in specific clinical situations.” There are guidelines for lower leg ulcers and varicose veins—which are frequent causes of lower leg ulcers—overseas, but not in Japan. Moreover, only a few books have provided detailed explanations of the differential diagnosis of leg vein disorders, which account for approximately 80% of all causes of lower leg ulcers, or of compression therapy/surgical therapy, which play important roles in their treatment.

Varicose veins are treated in multiple clinical departments. However, as patients often visit the dermatology department first for leg ulcers, the present Guidelines for the Management of Lower Leg Ulcers and Varicose Veins were prepared in consideration of the importance of the dermatologist's role. Also, the disease concepts of chronic venous insufficiency (CVI) and chronic venous disorders (CVDs) and the CEAP (based on clinical, etiologic, anatomic, and pathophysiologic data) classification of these disorders are presented. The objective of the present guidelines is to properly guide the diagnosis and treatment of lower leg ulcers and varicose veins by systematically presenting evidence-based recommendations to support clinical decisions.

2 STATUS OF THE GUIDELINES FOR THE MANAGEMENT OF LOWER LEG ULCERS AND VARICOSE VEINS

The Wound, Pressure Ulcer, and Burn Guidelines Committee (Table 1) is composed of members delegated by the Board of Directors of the Japanese Dermatological Association (JDA). It has met and produced written deliberations several times since October 2008, and has drafted a commentary on wounds in general and five treatment guidelines, including the Guidelines for the Management of Lower Leg Ulcers and Varicose Veins, by taking into consideration the opinions of the Scientific Committee and the Board of Directors of the JDA. The present Guidelines for the Management of Lower Leg Ulcers and Varicose Veins reflect the current standards of diagnosis and treatment in Japan. However, patients have varied backgrounds, including different underlying diseases, degrees of symptom severity, and complications. Therefore, physicians who perform diagnoses and treatments should determine an approach to diagnosis and treatment together with their patients, and the contents of their decisions need not always be in complete agreement with the present guidelines. Moreover, these guidelines cannot be cited as references in lawsuits or other disputes.

3 MAIN CHANGES TO THE SECOND EDITION

We updated all sections by collecting documents published since the publication of the first edition. In particular, we added clinical question 8 (CQ8), which addresses endovenous laser ablation for varicose veins, a procedure that became covered by the Japanese national health insurance after the writing of the first edition, and endovenous radiofrequency ablation, which became covered by national health insurance in 2014. We also rearranged the subsequent clinical question (CQs) for easier reading. While the addition of these new techniques has increased the options available within the treatment algorithm, differences have arisen in the indication for surgery depending on the facility performing the treatment. Therefore, these have been abbreviated.

4 SPONSORS AND CONFLICTS OF INTEREST

All expenses involved in the drafting of the Guidelines for the Management of Lower Leg Ulcers and Varicose Veins were borne by the JDA. No aid was provided by specific organizations, enterprises, or pharmaceutical companies. In the event that a committee member (Table 1) participating in the drafting of these guidelines was involved in the development of a specific, relevant drug, that member abstained from determining to what degree the item in question was recommended. Aside from that, no committee member has any conflict of interest relevant to the drafting of these guidelines to disclose.

5 COLLECTION OF EVIDENCE

Databases used: Medline, PubMed, Japana Centra Revuo Medicina Web, and Cochrane Database of Systematic Reviews (including all Evidence-Based Medicine Reviews). References obtained through manual search by each member were also added.

Search period: Searchable work published between January 1980 and December 2013 was reviewed. Recent published work of importance was added when considered appropriate.

Adoption criteria: Priority was placed on systematic reviews of randomized controlled trials (RCTs) and papers on individual RCTs. When these were not available, cohort studies and case-control studies were included. Although some reports of case-series studies were also used as references, published work on basic experiments was excluded.

6 CRITERIA FOR DETERMINATION OF THE EVIDENCE AND RECOMMENDATION LEVELS

The following criteria adopted in the Guidelines for the Diagnosis and Treatment of Malignant Tumors edited by the JDA were used as a reference to determine the evidence levels.

In addition, the Minds Handbook for Clinical Practice Guideline Development 2014 was used as a reference for the recommendation levels.

Recommendation levels:

If the level of recommendation cannot be determined, it is set as “none.” This includes cases in which a clear recommendation cannot be made.

7 REVIEW BEFORE PUBLICATION

Prior to the publication of these guidelines, the annual meetings of the JDA from 2012 to 2015 were used to present the committee's annual drafting progress, to solicit opinions from association members, and to make necessary revisions.

8 PLANS FOR UPDATES

The present guidelines are scheduled to be updated in 3 to 5 years. However, if a partial update becomes necessary, it will be presented on the website of the JDA, as appropriate.

9 DEFINITIONS AND EXPLANATIONS OF TERMINOLOGY

Lower leg ulcers: This term includes all ulcers that occur in the lower leg. They may be induced by various causes but are most often caused by venous disorders. In Western populations, approximately 70% to 80% of lower leg ulcers are reported to be venous ulcers. Approximately 10% of lower leg ulcers have arterial causes, and both venous and arterial causes are involved in some cases. Therefore, lower leg ulcers are mostly due to circulatory disturbances. Other causes include collagen disease, vasculitis, pressure ulcer, malignant tumor, infection, and contact dermatitis.

Venous ulcers of the lower leg: Venous ulcers of the lower leg are also called venous stasis ulcers, stasis ulcers, or simply venous ulcers. They are ulcers caused by disturbances of the venous return (venous stasis). Venous hypertension induces dermatitis, and the further addition of minor traumas such as contusions frequently triggers ulcer formation. These ulcers are frequently caused by primary varicose veins, although they may also be caused by secondary varicose veins. They often occur in the lower third of the lower leg to the dorsum of the foot.

Stasis dermatitis: Also called stasis eczema. Eczema/dermatitis caused by venous stasis or venous hypertension. It often occurs in the lower leg and is frequently caused by primary varicose veins, although it may also be caused by secondary varicose veins (Figure 1).

Venous hypertension of the leg: High venous pressure in the peripheral areas of the lower leg, even during leg exercise in a standing position (e.g., heel raises, stepping exercise). During rest in a standing position, venous pressure to the height of the central vein ranging from approximately 80 to 100 mm Hg is exerted on the ankle region even in a normal limb. However, when exercising the ankle, the pressure rapidly decreases to approximately 30 mm Hg due to the action of the skeletal muscle pump. In primary varices, due to venous valve insufficiency, the pressure only decreases to approximately 60 mm Hg even during exercise, and this pressure shows little decrease or even an increase when exercising the leg in cases of deep vein occlusion such as deep vein thrombosis (DVT). This condition in which the peripheral venous pressure of the leg does not decrease is called venous hypertension of the leg.

Varicose veins: A disease in which the superficial veins of the leg become dilated and tortuous. Despite the name, some lesions are not varicose. Varicose veins are divided into primary and secondary ones.

Primary varicose veins: These may be concisely called primary varices. This name refers to the condition in which the superficial veins of the leg become dilated and tortuous when the cause is in the dilated/tortuous veins themselves. Most varicose veins are primary.

Secondary varicose veins: These may be called secondary varices for concision. They are varices that occur secondarily, as the causes are not in the dilated/tortuous superficial veins themselves. Causes of secondary varices include not only DVT and thrombosis sequelae (post-DVT varices) but also pregnancy, intrapelvic tumor, arteriovenous fistula, and vascular tumor. Although post-DVT varices are common, caution is necessary in their diagnosis, as they may be totally indistinguishable from primary varices in examinations performed to check the patency of deep veins when reperfused after DVT. In these cases, the skeletal muscle pump of the lower leg does not function sufficiently because of deep venous valve incompetence (valvular reflux), and venous hypertension of the leg (venous stasis) persists. If the saphenous vein functions as a bypass for deep veins in the standing position as well, misdiagnosis of the condition as primary varices and surgical treatment for varices may result in postoperative exacerbation of the venous stasis and progression of the condition. In addition, there may be no clear valve reflux or deep vein occlusion despite a history of DVT.

Leg veins: Leg veins can be classified into superficial veins, deep veins, and communicating branches.

Superficial veins of the leg: Veins running in areas near the skin surface—including the great and small saphenous veins and their branches—are collectively called superficial veins of the leg. Approximately 10% to 20% of the leg's venous blood is normally returned via these superficial veins. Both superficial and deep veins have many valves, and the leg's venous return is accomplished by the action of the skeletal muscle pump and of these valves. If deep veins, which are the primary channels of venous return, are impaired by DVT, the superficial veins serve as a bypass, and secondary varices may develop if left untreated.

Great saphenous vein: One of the superficial veins of the leg. It originates anteriorly to the medial condyle, ascends on the medial side of the lower leg, runs on the medial side of the knee and thigh, and joins the femoral vein in the inguinal region. Many superficial veins that form its branches join it before it drains into the femoral vein. It also communicates with deep veins through communicating (perforating) branches. The great saphenous vein frequently consists of a single trunk, although it may be divided into two or three parallel vessels.

Small saphenous vein: The small saphenous vein is usually a single superficial vein that runs on the posterior side of the leg. It originates posteriorly to the lateral condyle, ascends to the popliteal region nearly in the center of the posterior aspect of the lower leg, and drains into the popliteal vein. Its cephalic portion, extending from one-third to one-half, is located under the fascia. It has branches connecting it to deep veins, and superficial veins connecting it to the great saphenous vein. The course of the small saphenous vein shows wide individual variation. While it drains into the popliteal vein in approximately 60% to 70% of individuals, it does not join the popliteal in some, or it joins the popliteal but ascends on the posterior side of the thigh until it joins the great saphenous vein in the inguinal region in others (Figure 2).

Deep veins of the leg: Veins that run in parallel with arteries in deep areas of the leg. The veins that share the names of arteries of the lower leg fuse below the knee to form the popliteal vein, which then becomes the superficial femoral vein, joins the great saphenous vein in the inguinal region, and drains into the external iliac vein. These veins normally return approximately 80% to 90% of the leg's venous blood.

Communicating branches: Also called perforating branches. These are veins with a diameter of ≤3 mm that connect superficial and deep veins. They have venous valves, and blood normally flows in one direction, from superficial to deep veins.

Insufficient communicating branches: Also called insufficient perforating branches. These are communicating branches that show reflux from deep to superficial veins due to valve insufficiency from venous stasis caused by leg varices.

Morphological classification of primary varices:

Primary varices can be classified from (1) to (4) as described below. Note that different types may be observed simultaneously.

Chronic venous insufficiency (CVI): Also called CVDs. CVI is defined as a “disease in which tiredness, edema, swelling, pain, secondary varices, eczema, skin sclerosis, and ulcers of the leg appear as a result of disturbances of the venous return to the heart due to some cause.” It is caused by persistent venous hypertension of the leg from untreated DVT sequelae or varicose veins. It is recommended to determine the definitive CEAP classification to decide on a treatment plan.

Varicose syndrome: Also called stasis syndrome. This collectively refers to symptoms induced by venous stasis of the leg (from the foot to the lower leg: edema, malaise/tiredness, stasis eczema, purpura, pigmentation, hemosiderin deposition, white atrophy, and lower leg ulcers). The syndrome is primarily caused by untreated primary varicose veins and DVT sequelae, and the treatment differs with the cause. The former should be treated with surgery of the varicose veins causing the symptoms, while the latter requires conservative treatments such as strict compression therapy. This syndrome is also called CVI or CVD.

CEAP classification: The CEAP classification adopted by the American Venous Forum in 1994 (revised in 2004) is widely applied to varicose diseases of the leg. In this classification, the clinical signs (C) are classified into 0 to 6, the etiology (E) into c, p, s, and n, the anatomic classification (A) are classified into s, p, d, and n, and the pathophysiological dysfunction (P) into r, o, and n (Table 2).

Deep vein thrombosis: DVT is primarily a condition in which thrombi are formed in the deep veins of the leg. Pulmonary embolism (PE) and DVT, which often concur, may be collectively called venous thromboembolism (VTE), or venous thrombosis. Virchow triad—(i) impairment of the endothelial cells, (ii) disturbance of the blood flow, and (iii) hypercoagulability—has been proposed as the cause of thrombosis. Recently, the view that DVT develops from thrombus formation in the soleal vein has also been presented. While its causes are diverse, DVT has been reported to occur in approximately half of patients after total knee replacement. While DVT and PE are occasionally called “economy class syndrome,” this is not an appropriate name, as the condition also appears in situations other than air travel.

Guidelines for the prevention of DVT: Guidelines for the prevention of pulmonary thromboembolism and DVT (VTE). DVT is a cause of PE that occurs frequently (particularly after surgery and childbirth) and often leads to unfortunate outcomes. In Japan, therefore, preventative measures and medications began to be covered by national health insurance in 2004.

Post-thrombotic syndrome: The symptoms induced primarily by venous hypertension of the leg in the chronic period after DVT. In that period, symptoms are alleviated by the development of collateral blood flows and the reperfusion of deep veins. However, if the poor development of collaterals or deep vein valve insufficiency (valvular reflux) persist, the skeletal muscle pump of the leg does not function adequately, and sustained stasis of the venous blood results in leg tiredness, edema, swelling, pain, secondary varices, eczema, pigmentation, dermal sclerosis, and ulcers.

Thrombophlebitis: Phlebitis primarily caused by thrombosis of the superficial veins (distinct from DVT occurring in deep veins). It complicates conditions such as Buerger disease, Behçet disease coagulation/fibrinolytic abnormalities, thrombocytosis, and malignant tumor. However, in the leg, it often occurs with venous stasis. In the arm, it is often iatrogenic, being caused by intravenous injection.

Congenital varices: Inconspicuous congenital varices often cause venous dilation starting in children from school age. While their symptoms are similar to those of adult varices, stripping surgery is often indicated if the deep veins are patent. A characteristic congenital varices condition is Klippel-Trenaunay syndrome, which is accompanied by varicose veins, angioma (including venous anomalies), and elongation of the affected limb.

9.1 Explanations of diagnoses/tests

Doppler auscultation: Examination of the blood flow state with an ultrasound Doppler auscultator (Figure 3). This examination is indispensable to the diagnosis of peripheral arterial occlusive disease and leg vein diseases. Doppler auscultators are the most useful diagnostic tool to use in initial examinations to screen for varicose veins of the leg and lower leg ulcers, as they are compact, lightweight, and easy to operate. Doppler auscultation must be performed with the patient in a standing position, using a probe coated with a sufficient amount of jelly to avoid compression of the skin. This allows for the confirmation of the presence of blood flow in the deep veins and of reflux in superficial veins (i.e., in the great and small saphenous veins and their branches). If a reflux murmur is heard when inducing reflux through the Valsalva maneuver or the lower leg milking maneuver, the condition is abnormal. Typically, no reflux murmur is heard in the superficial veins.

Trendelenburg test: A conservative test used to examine the valve function of the great and small saphenous veins and the perforating branches. A patient with varicose veins is placed supine with the legs elevated to empty the superficial veins and varices (if varices are not emptied in this position, the deep veins are occluded or the varices themselves are filled with thrombi). While maintaining the elevation of the legs, a tourniquet (rubber band) is applied to the femoral region. The patient is asked to stand up, and the examiners verify whether the varices become filled with blood. If they fill immediately, there may be incompetent communicating branches at the foot side of the tourniquet or reflux of the small saphenous vein. If the varices show no marked swelling, there is only reflux of the great saphenous vein, which is prevented by the tourniquet. If swelling of the varices is confirmed after removing the tourniquet, valvular incompetence of the great saphenous vein is considered likely.

Perthes test: A conservative test to examine the patency of deep veins and the valve function of perforating branches. A tourniquet is applied to the femoral region of a patient with varicose veins after confirming the presence of varices in a standing position. The patient is then asked to perform a stepping movement or heel raises in this position. If the swelling of the varices is reduced by the action of the skeletal muscle pump, the deep veins are inferred to be patent. If no marked change is observed, incompetence of the communicating branches at the foot side of the tourniquet is inferred. On the other hand, if the varices are exacerbated, obstruction of the deep veins is suspected.

Leg venography: This test is primarily performed to confirm patency of the deep veins, and is conducted in a semi-standing or standing position using a fluoroscopic table. After tourniquets have been applied to the thigh, lower leg, and ankle, the dorsalis pedis vein is punctured, a contrast agent is injected, and the influx of the contrast agent into the deep veins is imaged at the same time as it is confirmed fluoroscopically. Once the deep veins are visualized, the tourniquets are released, and the branches and varicose veins are observed. Although this is an invasive test, its range of visualization is limited.

Contrast-enhanced computed tomography (CT) of the leg: A contrast agent is generally injected through an arm vein, and CT images are obtained in the venous phase of the leg by adjusting the timing of the scanning to enhance the imaging ability of the leg veins. The preparation of three-dimensional images is useful as a preoperative examination. In addition, if there are thrombi, they can be observed as filling defects.

Color Doppler ultrasonography of the leg: Although the courses of the veins and varices and the locations of the branches and perforating branches can be examined with ultrasound tomography, the simultaneous use of duplex scanning enables a close examination not only of the superficial veins, but also of the presence of perforating branch incompetence and of the state of the deep veins.

Magnetic resonance venography of the leg: A noninvasive examination of the leg veins using magnetic resonance imaging (MRI). By emphasizing liquid signals based on T2-weighted imaging and by specifying the direction of the blood flow, veins can be visualized selectively by eliminating the effects of the arteries. This examination provides detailed information about the deep and superficial veins and their communicating branches. When three-dimensional images are prepared, it is the most useful preoperative evaluation procedure. However, clear images may not be obtained if lower leg edemas or similar conditions are present. In addition, it is contraindicated in patients who have a heart pacemaker or metallic foreign material in their body (Figure 4).

Venous plethysmography of the lower leg: A noninvasive examination of the lower leg veins. The venous return function is evaluated by measuring the changes in the lower leg volume associated with changes in the body position, exercise loading, and avascularization. Variations of this test include air plethysmography, photoplethysmography, and strain gauge plethysmography, although air plethysmography has recently become the most commonly used. The venous return function of the lower leg skeletal muscle pump can be evaluated/quantified through muscle pump plethysmography, and the compression method can be used to check for circulatory disturbance of the deep veins.

Ankle brachial pressure index (ABI or ABPI): The blood pressure is measured in the arm and leg (usually in the posterial tibial and dorsalis pedis arteries), and their ratio (leg blood pressure/arm blood pressure) is calculated. The normal range is 1.0 to 1.4, while values of ≤0.9 are generally considered abnormal. However, the ABI may be normal in arteriosclerosis of the leg. Currently, this examination can be performed rapidly with a blood pressure/pulse wave measurement device (ABI/PWV). These devices simultaneously measure the arterial pressure and the pulse wave velocity in the four limbs, allowing the differentiation between a normal state and arteriosclerosis.

9.2 Explanation of treatments

Compression therapy: The most important conservative treatment for varicose veins, DVT, and lymphedema. Elastic bandages or elastic stockings are used. If there are ulcers, it is easy to use an elastic bandage that can be wound around the limb while adjusting the compression pressure. If there are no ulcers, stockings are convenient. However, caution must be taken in patients with peripheral arterial stenosis of the leg. It has been reported that compression therapy should particularly be avoided in patients with ABI values <0.8. When there are ulcers and stronger compression pressure is needed, an elastic bandage with a lower elasticity is sometimes effective when concomitantly used as a second layer of wrapping to provide pressure. Elastic bandages or stockings are applied immediately after rising in the morning, and are worn until bedtime. The legs are elevated by approximately 10 cm during sleep (by placing two cushions under the lower legs). Compression therapy should be continued in limbs with varices not treated surgically, and for 2 to 3 months after surgical treatment.

Elastic bandages: Stretchable bandages used for compression therapy. Elastic bandages are relatively inexpensive and allow for adjustment of the compression force and area. However, they are prone to being displaced or loosened, and they can apply force unevenly depending on how they are applied. Nevertheless, if there are ulcers, they are easier to use than stockings as they cause less pain from the compression and are less likely to allow displacement of the gauze covering the ulcers. They should be applied starting from the foot, and a 10-cm-wide bandage should be used to compress the lower leg, while a 15-cm-wide product should be selected to compress the entire leg. Some practice is required to be able to wrap the bandage around the leg in a way that provides uniform compression. Therefore, there are self-adherent elastic bandages that stick to themselves just by wrapping, and others that come with guides to make them easy to apply for uniform pressure (Figure 5).

Elastic stockings/socks: Stockings used to treat leg vein disorders and lymphedema. Elastic stockings are also used to prevent intraoperative or postoperative DVT. They exist as pantyhose, thigh-high stockings, and knee-high socks, with or without a toe section. They are sold by multiple manufacturers, and are labeled by size (SS, S, M, L, LL) and compression force (strong, medium, mild) to allow for selection according to the length and thickness of the leg. They also have various material thicknesses, and thicker fabric is preferable for lymphedema treatment. Sufficient explanations must be provided to patients receiving compression therapy with stockings. They must be told that stockings of an appropriate size are difficult to put on at first, that those easy to put on are not a good fit for their leg (they lack compression force), and that rubber kitchen gloves make them relatively easy to put on (Figure 6). Devices providing assistance to put on elastic stockings are also sold (Figure 7).

Support stockings/socks: These elastic stockings are articles of clothing marketed as “tightening stockings” or “compression stockings.” As sufficient grip strength is needed to put on medical stockings, elderly patients and those with reduced grip strength may be recommended to wear multiple layers of support stockings.

Surgery for varicose veins: Comprehensive term for surgical treatments of primary varicose veins. Procedures such as stripping, high ligation, sclerotherapy, endovenous ablation, and subfascial endoscopic perforator vein surgery are insured treatments. Regardless of the procedure selected, the surgery must be performed after checking the patency of the deep veins, marking the locations of the veins by Doppler auscultation and ultrasound examination with patients in the standing and recumbent positions, and determining the site of the surgery. The different surgical methods are described below.

Stripping: This is the procedure of choice when the dilation of the saphenous vein is pronounced (criterion for thick varices: the diameter of the great saphenous vein in the inguinal region is ≥8 mm when standing, although this criterion differs between facilities) or when there is a marked venous tortuosity. It is a radical treatment that involves extraction of the saphenous vein that has developed valvular incompetence. It provides consistent results as it also blocks incompetent communicating branches. Recently, an increasing number of facilities have been using tumescent local anesthesia, which allows the patient to move their ankle joint or to walk immediately after the operation, as it prevents the postoperative development of venous thrombi.

After high ligation and separation of the great saphenous vein in the inguinal region, a stripping wire is inserted from the great saphenous vein in the lower leg toward the inguinal region, an olive head is affixed, and the vein is stripped (Babcock stripping); or the vein is tied to the stripping wire so that it can be invaginated and stripped (invagination stripping). While the latter causes less nerve damage, caution is needed, as the vein can rupture during the stripping procedure. Although the procedure is occasionally called radical varicectomy, recurrence (i.e., reflux via another superficial vein) is reportedly observed in 30% to 40% of patients 5 years after surgery.

High ligation: This procedure is selected when the dilation of the saphenous vein is moderate. It is performed under local anesthesia. A skin incision is made slightly inferiorly to the inguinal crease for great saphenous varices, and in the popliteal region for small saphenous varices. The subcutis is detached to expose the saphenous vein, the site of its drainage into a deep vein is identified, and the saphenous vein is removed after double ligation to prevent stenosis. The branches that drain into deep veins are simultaneously ligated and separated. Recurrence has been observed when high ligation is performed alone. Therefore, many facilities will perform ligation and separation at three sites (namely, in a high position and above and below the knee), and will follow it up with sclerotherapy at a later date.

Sclerotherapy: A treatment for small varices that involves the injection of a sclerosing agent into the varices. Polidocanol is covered by national insurance. After using a fine needle (e.g., 27 G and 30 G) to inject 0.5% to 3% polidocanol into the varices, the site is compressed with an elastic bandage (compression sclerotherapy). Recently, a method by which polidocanol is mixed with air, foamed, and injected (foam sclerotherapy) has also been used. However, this procedure is not indicated for varicose veins and saphenous varices exceeding 8 mm in diameter in a standing position. Therefore, it is usually not performed alone for varicose veins that may cause leg ulcers.

Endovenous ablation for varicose veins of the leg: The efficacy of this procedure is equal to that of stripping for saphenous vein varicosities. It involves ablating the varicosities using a catheter. Both endovenous laser ablation (980 nm and 1470 nm) and radiofrequency ablation are covered by national health insurance. The procedure is performed by puncturing the saphenous vein under ultrasonic guidance, anesthetizing the area of the vein to ablate with tumescent local anesthesia, and inserting the tip of laser fibers or a radiofrequency ablation device into the saphenous vein inferiorly to its junction with a deep vein under ultrasonic guidance. The vein is then ablated under ultrasonic confirmation, and the process is repeated while withdrawing the ablation device in order to ablate/occlude the saphenous vein. As such, this procedure is not indicated in the presence of marked tortuosity or when the diameter of the varicosity is large. Since this surgery carries the risk of formation of an endovenous heat-induced thrombus near the junction of the saphenous vein and the deep vein that can result in DVT, repeated postoperative ultrasonic screening is required. In addition, national health insurance can only be applied to endovenous ablation when it is performed by a physician who has undergone specific training.

Indications and exclusion criteria described in the “Guidelines for Endovenous Treatment of Varicose Veins of the Leg” 1. Indications (i) Deep veins are patent. (ii) The average diameter of the saphenous vein 5–10 cm distal to the saphenous-femoral junction (SFJ) or the saphenopopliteal junction is at least 4 mm. Moreover, an average diameter no greater than 10 mm is recommended. (iii) There are symptoms of varicose veins (e.g., tiredness, pain, edema, and leg cramps) or there is stasis dermatitis. (iv) Endovenous treatment is not indicated when the terminal valve is competent and no valvular incompetence is found at the SFJ, even if it is found in the saphenous vein. However, this excludes cases in which the Dodd perforator is a cause of reflux. 2. Exclusion criteria: The exclusion criteria for endovenous treatment are as follows. (i) CEAP clinical class C1 (spider/reticular varicose veins) (ii) The patient has DVT or a history of DVT. (iii) The patient has an arterial blood flow disorder. (iv) The patient has difficulty walking. (v) The patient has multiple organ failure or disseminated intravascular coagulation. (vi) The patient is taking oral contraceptives or hormones. (vii) The patient has severe heart disease. (viii) The patient is in shock or pre-shock. (ix) The patient is pregnant or may be pregnant. (x) The patient is undergoing steroid therapy. (xi) The patient has Behçet disease. (xii) The patient is taking osteoporosis medicine (raloxifene) or multiple myeloma medication (thalidomide). (xiii) The patient has predisposing factors to thrombosis (e.g., protein C deficiency, protein S deficiency, antithrombin III deficiency, and antiphospholipid syndrome).

• Drawn from Jpn J Phleb. 2010;21(4):289–309.

Subfascial endoscopic perforator vein surgery: This procedure is indicated when pigmentation, sclerosis, atrophy, or ulcers are present across a large area of the leg skin. It is also indicated if incompetent perforating branches are identified via ultrasound, reflux is observed in these veins, or if previous surgery for varicose veins is expected to be insufficient. This procedure replaces open perforator ligation (Linton procedure). An endoscope is inserted from the cephalic side of the location of the incompetent perforating branch, and the latter is ablated/removed subfascially, or is ligated using clips.

External medications: These are drugs applied through the skin or directly to skin lesions for local treatment. They are prepared by compounding various active ingredients with a base.

Wound-dressing materials: Wound-dressing materials can be classified into dressing materials (modern dressing materials) and medical materials such as gauze (classic dressing materials). The former are medical materials designed to provide an optimal environment for wound healing by maintaining a moist environment. They must be used selectively according to the state of the wound and the amount of exudate. The latter types allow the wound to dry and cannot maintain a moist environment if the amount of exudate is low. Other medical materials, aside from conventional gauze, that provide an optimal environment for wound healing by covering the wound and maintaining a moist environment, may also be called wound-dressing materials or dressing materials.

Dressing materials: Modern wound-dressing materials used to create a moist environment for wounds. Conventional sterilized gauze is excluded.

10 BASIC PRINCIPLES BEHIND THE GUIDELINES AND THE DIAGNOSTIC AND THERAPEUTIC ALGORITHMS

The basic principle informing the design of the present guidelines is to assist the differential diagnosis of disturbances of the venous return, which are the predominant cause of lower leg ulcers, and the selection of appropriate treatment. In venous ulcers of the lower leg, it is important to treat the cause, venous stasis (venous hypertension). Therefore, while our algorithm includes compression therapy as the most important element, it also shows the selection of surgery and sclerotherapy for primary varices, and the necessity of strict compression therapy for secondary varices.

Figure 8 shows a diagnostic and therapeutic algorithm based on the above basic principle.

11 SUMMARY OF CLINICAL QUESTIONS

Table 3 shows the clinical questions (CQs), the level of recommendation, and a description of the recommendation for each.

CQ1: If leg ulcers are present, is it useful to evaluate leg veins as a potential cause?

Description of the recommendation: As a majority of leg ulcers are caused by venous circulatory disorders, we recommend evaluating the possibility of leg ulcers caused by primary or secondary varicose veins.

Level of recommendation: 1C.

CQ2: When evaluating leg ulcers, is it useful to perform Doppler auscultation of the leg veins?

Description of the recommendation: We recommend Doppler auscultation of the leg veins with the patient in a standing position for leg ulcer evaluation.

Level of recommendation: 1C.

CQ3: Is compression therapy useful for leg ulcers caused by primary or secondary varicose veins?

Description of the recommendation: Compression therapy for venous leg ulcers leads to faster ulcer improvement and a higher healing rate. Therefore, we strongly recommend compression therapy for leg ulcers caused by primary or secondary ulcers.

Level of recommendation: 1A.

CQ4: Is debridement useful for leg ulcers (caused by primary or secondary varicose veins) that have necrotic material?

Description of the recommendation: The removal of necrotic material from leg ulcers speeds up their reduction. Therefore, we recommend debridement, particularly active surgical debridement.

Level of recommendation: 1C.

CQ5: Are topical agents or dressing materials useful for leg ulcers caused by primary or secondary varicose veins?

Description of the recommendation: We propose the use of topical agents and dressing materials as one option. However, the fundamental treatment for venous leg ulcers is compression therapy.

Level of recommendation: 2A.

CQ6: Is the use of imaging to confirm the patency of deep veins useful for varicose veins of the leg?

Description of the recommendation: For varicose leg veins, we recommend confirming the patency of deep veins with vascular ultrasound (color Doppler ultrasound), contrast-enhanced CT of the venous phase, magnetic resonance venography, leg venography, or similar methods as part of the preoperative examination.

Level of recommendation: 1A.

CQ7: Are stripping and high ligation useful for leg ulcers caused by primary varicose veins?

Description of the evaluation: We recommend surgery for varicose veins (stripping, high ligation) on the saphenous vein for leg ulcers caused by primary varicose veins. Regarding endovenous ablation, which yields equivalent results to surgery for varicose veins, see CQ8.

Level of recommendation: 1A.

CQ8: Is endovenous ablation (laser, radiofrequency) useful for leg ulcers caused by primary varicose veins?

Description of the recommendation: Endovenous ablation surgery of the legs with laser or radiofrequency has the same effectiveness as the conventional treatments of stripping and high ligation. Therefore, we recommend endovenous ablation for leg ulcers caused by primary varicose veins.

Level of recommendation: 1A.

CQ9: Is sclerotherapy useful for leg ulcers caused by varicose veins?

Description of the recommendation: For leg ulcers caused by small varices (excluding the saphenous vein—i.e., side branch varices, reticular varices, spider varices), we recommend the use of sclerotherapy together with compression therapy (1A). However, because the use of polidocanol (Polidocasklerol) in the main trunk of the saphenous vein is not covered by insurance in Japan, we propose it as one option for saphenous varicose veins (2A).

CQ10: Are skin grafts useful for leg ulcers caused by primary varicose veins?

Description of the recommendation: We propose skin grafts as one option for the treatment of leg ulcers caused by primary varicose veins. However, the basic treatments for leg ulcers caused by primary varicose veins are surgery for varicose veins (stripping, high ligation, endovenous ablation) and compression therapy.

Level of recommendation: 2A.

CQ11: Is surgery for varicose veins (stripping, high ligation, endovenous ablation) contraindicated for secondary varicose veins?

Description of the recommendation: If the deep veins of a patient with secondary varicose veins caused by DVT are not patent, there is an extremely high risk that surgery for varicose veins will worsen the venous circulation. Therefore, we recommend not performing surgery for varicose veins.

Level of recommendation: 1A (we recommend not performing the procedure).

CONFLICT OF INTEREST STATEMENT

Tamihiro Kawakami, Minoru Hasegawa, and Hideki Fujita are editorial board members of the Journal of Dermatology and co-authors of this article. To minimize bias, they were excluded from all editorial decision-making related to the acceptance of this article for publication. Takafumi Kadono is the Editor-in-Chief of the Journal of Dermatology and a co-author of this article. He was excluded from editorial decision-making related to the acceptance and publication of this article. Editorial decision-making was handled independently by deputy editors to minimize bias.