Journal of Vascular Surgery
Volume 49, Issue 3 , Pages 804-808, March 2009

Leg ulcer treatment

  • Philip D. Coleridge-Smith, MD, FRCS

      Affiliations

    • Corresponding Author InformationCorrespondence: Philip D. Coleridge-Smith, MD, FRCS, The Bridge Clinic, Bridge Rd, Maidenhead SL6 8DG, UK

British Vein Institute, London, United Kingdom

Received 10 December 2008; accepted 7 January 2009.

Jan D. Blankensteijn, MD, Section Editor

Article Outline

Venous ulcers continue to cause problems for patients and health care systems. These are painful and unpleasant for the patient and expensive for health care providers to treat. This brief review highlights effective methods of management. There is level 1 evidence of the efficacy of compression (bandaging or stockings) in healing ulcers as well as maintaining healing. Patients with superficial saphenous reflux, with or without perforating and deep vein incompetence, benefit from superficial venous surgery. This does not speed ulcer healing but is effective at preventing recurrence after healing with compression. Minimally invasive methods of managing incompetence of superficial saphenous trunks, including endovenous laser ablation, radiofrequency ablation, and foam sclerotherapy are probably also effective in treating patients with venous leg ulcers. Perforating vein ligation is commonly combined with superficial venous surgery for leg ulcer patients, but no systematic data are available to define the role of this treatment. Some centers use deep vein reconstruction to restore competence to deep vein valves. Insufficient data have been published to allow any general recommendation to be made for this treatment. A limited number of drugs have efficacy in promoting leg ulcer healing. They may be used in combination with compression treatment in patients with ulcers refractory to other methods of management. No particular ulcer dressing has been shown to be effective in speeding ulcer healing.

 

Venous ulcers have been treated by bandaging and topical applications for thousands of years. More recently, surgical intervention and drug treatments have been added to these ancient methods. So what is the most appropriate way of managing a venous leg ulcer? It is essential to understand the pathologic mechanisms causing the ulcer, because leg ulceration may be the result of venous disease, arterial disease, diabetes, neuropathies, vasculitis, infection, and neoplasm, to mention only the most frequent. Combinations of these occur commonly, increasing the difficulties for the clinician. This subject is considered in detail in the Handbook of the American Venous Forum.1 Duplex ultrasound imaging is a crucial element in diagnosis, and a consensus statement of methods and interpretation of data from such investigations has been published.2, 3

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Results of data search 

From a literature search in PubMed and the Cochrane Database, studies were selected evaluating the effect of three classes of therapy for venous ulcer: compression, surgical, and drug treatment.

Compression treatment 

Bandaging of leg ulcers is an ancient treatment that has been used since 3500 bc. In recent years, studies have confirmed that compression bandaging and the application of stockings leads to healing of venous leg ulcers. A detailed review of the efficacy of compression treatments in venous disease has been published by Partsch et al.4 They conclude that compression stockings, particularly those of 20 to 30 mm Hg or greater, and compression bandaging lead to reductions in edema, venous diameter, and venous reflux and to improvement in the function of the calf muscle pump.

There is level 1A evidence that compression bandaging promotes the healing of venous ulcers and level 1B evidence for strong compression hosiery (30-40 mm Hg). There is also level 1A evidence that compression hosiery (30-40 mm Hg) prevents recurrence of ulceration after healing. Therefore, the first-line treatment for venous leg ulcers should be compression bandaging or strong hosiery where this is not contraindicated; for example, in patients with clinically significant peripheral artery disease. Once leg ulceration has healed, strong compression stockings should be prescribed to maintain healing. Intermittent pneumatic compression has also been used for the management of leg ulcers, but the evidence for this is weak, confined to limited clinical series.5 Studies detailing compression treatment are summarized in Table I.

Table 1. Studies addressing the efficacy of compression in venous disease
Study (first author)Study designPopulation/procedureNo. of patients/studies citedMain conclusions
Partsch4Systematic reviewCompression stockings, bandages, intermittent pneumatic compression. CEAP: C1-C6174 articles, 2548 patientsIn C6 patients: Compression bandaging effective (level 1A), compression hosiery effective (level 1B). In C5 patients: Compression hosiery prevents recurrence of ulcers
Nelson5Systematic reviewLeg ulcers, intermittent pneumatic compression, and continuous compression techniques. CEAP: C67 RCTs, 367 patientsIntermittent pneumatic compression may improve healing vs no compression; insufficient evidence to draw conclusions on comparison with bandaging and compression stockings

RCT, Randomized controlled trial.

Surgical treatment 

Surgical treatment for venous ulcers has been used for many years. Stripping of the saphenous vein was described 100 years ago both by Keller6 and by Babcock,7 who used slightly different techniques to strip the vein from groin to ankle. More recently, stripping of the great saphenous vein below the knee has been abandoned to avoid the risks of injury to the saphenous nerve. The Oesch pin-stripping technique is common,8 but several other methods are also used. Open perforating vein surgery was commonly used 30 to 50 years ago, but often led to wound-healing problems.9, 10 In more recent years, subfascial endoscopic surgery (SEPS), which carries less risk of wound-healing problems, has been used to ligate incompetent perforating vein.11

The role of saphenous stripping was investigated in the Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) study.12 This clinical trial randomized 500 patients from three hospitals to undergo treatment of venous leg ulcers by compression alone or combined with superficial saphenous surgery. After 24 weeks, ulcers had healed in 65% of patients in both groups, but recurrent ulceration occurred in 12% of the compression and surgery group compared with 28% in the compression alone group. Superficial venous surgery is effective at maintaining healing of venous ulcers and should be offered to patients even in the presence of concomitant deep vein incompetence.

The role of perforating vein surgery for venous ulcers has not been studied in such detail. The procedures originally described by Linton and Cockett are not in common use. SEPS has replaced these, but no detailed clinical trial has established the role and value of this operation. The North American SEPS Registry showed a cumulative healing rate of 88% at 1 year, although concomitant superficial venous surgery was done in many patients.13 Ulcer recurrence in this series was 16% at 1 year and 28% at 2 years, similar to that reported in the ESCHAR study. In another small series, a 13% ulcer recurrence rate was reported at 5 years after a combination of SEPS and superficial venous surgery.14 The precise role of perforating vein surgery is not well defined at present, but is widely used in combination with superficial venous surgery where incompetent calf perforating veins are identified on duplex ultrasound imaging.

A number of reports have been published of deep vein surgery to address deep vein incompetence that results in symptomatic venous disease.15, 16 A Cochrane Review of available controlled studies is available.17 The authors conclude that although valvuloplasty may achieve moderate and sustained clinical improvement, the available clinical trials provide insufficient data at present to make more general recommendations. At present, this treatment remains in limited clinical use in specialized centers. Surgical treatment is summarized in Table II.

Table II. Surgical treatment—the outcome of commonly used techniques
Study (first author)Study designPopulation/procedureNo. of patients/studies citedResults/main conclusions
Barwell12RCTPatients with leg ulcers or recently healed ulcers; randomized to compression or compression plus superficial saphenous surgery. CEAP: C5 and C61418 patients screened, 500 randomizedSuperficial saphenous surgery did not influence ulcer-healing rate, but reduced the 12-mon recurrence rate from 28% to 12%.
Gloviczki1Treatment registryPatients with healed or open venous ulcers; SEPS alone or combined with superficial saphenous surgery (71% of cases). CEAP: C5 and C6146 patientsUlcer healing: 88% at 12 months. Cumulative ulcer recurrence: 16% at 1 y; 28% at 2 y. Symptoms and signs of venous disease improved by SEPS combined with superficial saphenous surgery.
Iafrati14Clinical seriesPatients with healed or open venous ulcers. SEPS alone combined with superficial saphenous surgery (56% of limbs). CEAP: C5 and C645 patients (51 limbs)Ulcer healing: 74% at 6 mon. Recurrence after healing: 13% at 5 y. Combined SEPS and superficial saphenous surgery is useful in the management of severe venous disease.
Hardy17Systematic reviewPatients with severe venous disease undergoing ligation of superficial incompetent veins and deep vein valvuloplasty (external) or ligation of superficial veins alone. CEAP: C4-C52 RCTs, 112 patientsModerate improvements in clinical symptoms and reductions in ambulatory venous pressures reported. Clinical trials too small to recommend surgical valvuloplasty to a wider group of patients.
Masuda15Clinical seriesPatients with severe venous disease managed by deep vein valvuloplasty (various techniques). CEAP: C4-C648 patients (51 limbs)Good outcome observed in primary non-thrombotic deep vein incompetence (no or minor venous disease symptoms) in 73% of limbs vs 43% of post-thrombotic limbs.
Perrin16Clinical seriesPatients with severe venous disease managed by valvuloplasty (n = 85), transposition (n = 18), transplantation (n = 32), or Psathakis' technique II (n = 9). CEAP: C3-C6133 patients (144 limbs)DUS showed that valvular competence was restored in 79% of limbs (valvuloplasty), 71% (valve transposition), and 48% (valve transplantation). Leg ulcers remained healed in 50% of post-thrombotic limbs and 75% of limbs with primary valvular incompetence. Deep vein reconstruction most appropriate in latter group.

DUS, Duplex ultrasound imaging; RCT, randomized controlled trial; SEPS, subfascial endoscopic surgery.

New methods of treating varicose veins have gained widespread support in many countries and include endovenous laser and radiofrequency ablation as well as ultrasound-guided foam sclerotherapy. Limited clinical series of treatment of saphenous incompetence in patients with leg ulcers have been reported using endovenous laser ablation,18, 19 radiofrequency ablation,20 and foam sclerotherapy21 (Table III). No clinical trial has been published comparing these treatments with surgical intervention in patients with leg ulcers. A recently published meta-analysis suggests that endovenous treatments are as effective as surgical methods at obliterating truncal saphenous incompetence,22 so until more definite evidence is available, the conclusions of the ESCHAR study likely apply to these methods as well. Endovenous treatments are less invasive than conventional surgery, which may be advantageous in more elderly patients who are affected by leg ulcers.

Table III. New treatments for varicose veins, use in the management of venous ulcers
Study (first author)Study designPopulation/procedureNo. of patients/studies citedMain conclusions
Viarengo18RCTPatients with venous leg ulcers were treated by compression bandaging alone or ELA of incompetent saphenous trunks. CEAP: C652 patients randomized12 mon post-treatment: 82% of ELA treated patients and 24% of the compression group had healed ulcers. ELA of incompetent saphenous trunks promotes venous ulcer healing.
Sharif19Clinical seriesPatients with severe venous disease managed by endovenous laser ablation. CEAP: C4-C620 patients (23 limbs)The cumulative healing rates: 3 mon, 87%; 12 mon, 100%; 22 mon, 95%. ELA is effective in the treatment and prevention of venous ulcers.
Puggioni20Clinical seriesPatients with moderate to severe venous disease managed by a combination of ELA, RFA, and SEPS. CEAP: C2-C692 patients (130 limbs)The treated saphenous trunk was occluded in 94% of patients, with few adverse events. Clinical outcome not reported.
Pascarella21Clinical seriesPatients with severe venous disease: C4, 7 limbs; C5, 18 limbs; C6, 35 limbs. Three treatment groups were involved: compression alone, foam sclerotherapy after failed compression, and foam sclerotherapy.44 patients (60 limbs)All patients in the compression alone group and the failed compression and foam sclerotherapy groups had healed ulcers in 6 wks. With foam sclerotherapy alone, all 11 ulcers healed within 4 weeks. The combination of compression treatment and foam sclerotherapy is effective in managing severe venous disease.
Van den Bos22Meta-analysisPatients with venous disease managed by surgery, RLA, RFA, and foam sclerotherapy. Main outcome measure: ablation of saphenous trunk on US imaging. CEAP: C2-C6119 studies, ? patients (12,320 limbs)At a mean follow-up of 32 months, the saphenous obliteration rate was surgical stripping, 78%; foam sclerotherapy, 77%; RFA, 84%; and ELA, 94%. Minimally invasive treatment for varicose veins is at least as effective as surgery.

ELA, Endovenous laser ablation; RFA, radiofrequency ablation; SEPS, subfascial endoscopic surgery; US, ultrasound.

Drug treatment 

A wide range of drugs have been used to help heal venous leg ulcers; however, only a very limited number have presented evidence of efficacy (Table IV).23, 24, 25, 26, 27 Pentoxifylline, a methylxanthine that has been used in the management of intermittent claudication, has been the subject of a Cochrane Review in the context of its use in the management of venous ulceration.23 The authors identified 11 studies and concluded that this drug is effective in promoting leg ulcer healing when used in combination with compression treatment. A further meta-analysis was published of four controlled trials that studied the use of micronized purified flavonoid fraction (MPFF) combined with compression treatment.24 The mean healing time was 16 weeks in patients treated with MPFF plus compression compared with 21 weeks in patients with compression alone.

Table IV. Drug treatment and dressings in the management of venous disease
Study (first author)Study designPopulation/procedureNo. of patients/studies citedResults/main conclusions
Jull23Meta-analysisPatients with venous ulcers managed by compression and placebo or oral pentoxifylline. CEAP: C612 trials, 864 patientsPentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (RR, 1.70; 95% CI, 1.30-2.24). Pentoxifylline is an effective adjunct to compression bandaging for treating venous ulcers.
Coleridge-Smith24Meta-analysisPatients with venous ulcers managed by compression and placebo or MPFF taken orally. CEAP: C65 trials, 723 patientsThe chance of an ulcer healing >6 months was 32% better in patients treated with adjunctive MPFF than in those managed by conventional therapy alone (RRR, 32%; CI, 3%-70%). MPFF treatment accelerates venous ulcer healing.
Martinez25Meta-analysisPatients with any venous disease treated with phlebotonic drugs. CEAP: C1-C644 trials, 4413 patientsSome evidence of efficacy in the management of edema, but not enough evidence exists globally to support the efficacy of phlebotonics for chronic venous insufficiency.
Ferrara26RCTPatients with venous ulcers were randomized to a daily intravenous infusion of iloprost or saline for 3 weeks. CEAP: C698 patients randomizedAll ulcers in the iloprost group healed ≤90 d; 84% of ulcers healed by 150 days in the saline (control) group. Iloprost infusions reduce length to venous ulcer healing.
Palfreyman27Meta-analysisPatients with venous leg ulcers managed with various dressing types. CEAP: C642 RCTs, 3001 patientsThe type of dressing applied beneath compression has not been shown to affect ulcer healing. No significant difference observed in healing rates between hydrocolloid dressings and simple, low-adherent dressings.

CI, Confidence interval; MPFF, micronized purified flavonoid fraction; RCT, randomized controlled trial; RR, relative risk; RRR, relative risk ratio.

A wider review of the efficacy of phlebotropic drugs has been published in a further Cochrane Review.25 The authors conclude that evidence is sufficient to show that phlebotonic drugs are generally effective in reducing edema in chronic venous disease; however, they could find insufficient evidence to support global use of these drugs. Patients in a clinical study received a daily infusion of saline or iloprost for 3 weeks combined with conventional treatment for varicose veins.26 After 90 days, ulcers had healed in all of the iloprost-treated patients, but in only half of the saline-treated patients. By 150 days, ulcers had healed in 85% of the saline group. No further study has been published.

Topical applications and the type of dressing used to manage leg ulcers have not been shown to influence ulcer healing.27

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Conclusions 

The first-line management of patients with confirmed venous ulcers is compression treatment with bandaging systems or strong compression hosiery, unless contraindicated. Surgical treatment of superficial saphenous trunks does not appear to speed ulcer healing but does prevent subsequent recurrence and should be offered to leg ulcer patients in whom superficial venous incompetence is present. No direct evidence of efficacy for the new endovenous techniques is available except from small clinical series, which report promising results. It is reasonable to conclude that saphenous ablation achieved by any of the endovenous methods will lead to similar outcomes as surgical treatment.

Perforating vein ligation using SEPS is performed in some centers, but much of the available data are from clinical series in which concomitant saphenous vein surgery has been performed. The precise role of this treatment remains undefined. Surgical reconstruction of deep vein valves is used in a small number of centers, but insufficient data are available to recommend this for general use.

Efficacy of two drugs, pentoxifylline and MPFF, has been found in meta-analyses. The use of these could be considered in patients with ulcers where compression and superficial vein ablation techniques have been ineffective.

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References 

  1. In:  Gloviczki P editors. Handbook of the American Venous Forum. London, UK: Hodder Arnold; 2009;
  2. Coleridge-Smith P, Labropoulos N, Partsch H, Myers K, Nicolaides A, Cavezzi A. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs–UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg. 2006;31:83–92
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 Competition of interest: none.

PII: S0741-5214(09)00014-7

doi:10.1016/j.jvs.2009.01.003

Journal of Vascular Surgery
Volume 49, Issue 3 , Pages 804-808, March 2009

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