CARDIOVASCULAR DISEASES

 Health Evidence Bulletins - Wales (logo)
Team Leader: Dr David Fone

Date of completion: 30.9.98

9: Varicose veins and leg ulcers

This bulletin is a supplement to, not a substitute for, professional skills and experience. Users are advised to consult the supporting evidence for a consideration of all the implications of a recommendation.

The Statements The Evidence
9.1 Clinical assessment
9.1a. Leg ulceration is strongly associated with obesity, immobility, varicose veins and a history of deep vein thrombosis. Arterial disease is present (alone or with venous disease) in 20% of cases of leg ulceration. Careful assessment of patients to identify arterial and small vessel disease is essential to prevent damage from inappropriate use of compression treatmentsi.
(Health gain notation – 1 "beneficial")		 i. Compression therapy for venous leg ulcers. Effective Health Care. Volume 3 Number 4. University of York: NHS Centre for Reviews and Dissemination, 1997
http://www.york.ac.uk/inst/crd/ehc34.htm
(Type IV evidence – review of observational evidence and case series)
9.1b. Ankle: brachial pressure index measured with a hand held Doppler ultrasound is better than manual palpation for excluding arterial disease, but is unreliable when carried out by inexperienced operators. Training of staff using ABPI can significantly improve reliabilityi.
(Health gain notation – 3 "trade-off between beneficial and adverse effects")		 i. Compression therapy for venous leg ulcers. Effective Health Care. Volume 3 Number 4. University of York: NHS Centre for Reviews and Dissemination, 1997
http://www.york.ac.uk/inst/crd/ehc34.htm
(Type IV evidence – review of observational evidece and case series)
9.1c. Early hospital specialist vascular assessment of leg ulcers, including duplex scanning of the arterial and venous systems, to determine the most appropriate early interventions and prevent chronic ulceration offers potential for clinical benefit and cost savingsi.
(Health gain notation – 2 "likely to be beneficial")		 i. Ruckley CV. Caring for patients with chronic leg ulcer. British Medical Journal 1998;316:407-8
(Type V evidence – expert opinion)
9.1d. Evidence-based guidelines for the care of patients with chronic leg ulcer are availablei.
(Health gain notation – 1 " beneficial")		 i. Scottish Intercollegiate Guidelines Network (SIGN). The care of patients with chronic leg ulcer. Edinburgh: Royal College of Physicians, 1998
http://www.show.scot.nhs.uk/sign/html/html26.htm
(Type V evidence – expert opinion)
9.2 Medical management
9.2a. Compression therapy using Unna’s boot, 2-layer, 4-layer or short stretch bandages improves healing rates compared to treatments using no compression, and may be more cost-effectivei.
(Health gain notation – 2 "likely to be beneficial")
Caveat: Six small primary studies were poor quality trials with ill-defined inclusion/exclusion criteria and method of randomisation. None stated blinded outcome assessment and only one included intention to treat analysis.		 i. Cullum N, Fletcher A, Nelson EA, Sheldon TA. Compression bandages and stockings in the treatment of venous leg ulcers. Cochrane Review [Updated 27 May 1998]. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type II evidence – review of randomised controlled trials)

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9.2b. High compression 3-layer elastic bandaging is more effective in healing at three months than single layer low compression using elastocrepe (odds ratio 2.26; 95% CI: 1.4, 3.7)i.
(Health gain notation – 2 "likely to be beneficial")
Caveat: Only three trials were included, two with blinded outcome assessment but intention to treat analysis was not stated.		 i. Cullum N, Fletcher A, Nelson EA, Sheldon TA. Compression bandages and stockings in the treatment of venous leg ulcers. Cochrane Review [Updated 27 May 1998]. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review and meta-analysis of 273 patients in three randomised controlled trials)
9.2c. Four layer high compression is more effective at healing ulcers by 24 weeks than single layer adhesive compression bandage. (odds ratio 2.2; 95% CI: 1.3, 3.5)i.
(Health gain notation – 2 "likely to be beneficial")
Caveat: Primary studies include one large trial not stating baseline comparability and without blinded outcome assessment and two poor quality pooled trials with significant heterogeneity.		 i. Cullum N, Fletcher A, Nelson EA, Sheldon TA. Compression bandages and stockings in the treatment of venous leg ulcers. Cochrane Review [Updated 27 May 1998]. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review and meta-analysis of 254 patients in three randomised controlled trials)
9.2d. Two small studies showed that at three and six month follow-up, more ulcers healed when intermittent pneumatic compression was used in addition to compression stockings or Unna’s boot (pooled odds ratio = 10.0; 95% CI: 2.96, 33.8)i.
(Health gain notation – 4 "unknown")
Caveat: Two poor quality trials were pooled. Further studies are required.		 i. Cullum N, Fletcher A, Nelson EA, Sheldon TA. Compression bandages and stockings in the treatment of venous leg ulcers. Cochrane Review [Updated 27 May 1998]. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review and meta-analysis of 67 patients in two randomised controlled trials)

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9.2e. Recurrence rates of healed ulcers at 3.5 years may be lower in patients using strong support from class 3 compression stockings than patients using class 2 (medium support) stockings (21% vs. 32%, p = 0.034); class 2 stockings were better toleratedi.
(Health gain notation – 2 "likely to be beneficial")
Caveat: The trial does not state baseline comparability and outcome assessment was not blinded.		 i. Harper D, Nelson E, Gibsom B, et al. A prospective randomised trial of class 2 and class 3 elastic compression in the prevention of venous ulceration. Phlebology 1995;1(suppl):872-73
(Type II evidence – randomised controlled trial of 300 patients with newly treated venous leg ulcers)
9.2f. Neither stanozolol or rutoside reduce recurrence of leg ulcers compared to placebo in patients also receiving class 2 compression stockingsi.
(Health gain notation – 6 "likely to be ineffective")		 i. Compression therapy for venous leg ulcers. Effective Health Care. Volume 3 Number 4. University of York: NHS Centre for Reviews and Dissemination 1997
http://www.york.ac.uk/inst/crd/ehc34.htm
(Type II evidence – randomised controlled trials)
9.2g. Care delivered in dedicated leg ulcer clinics by trained nurses following a treatment protocol involving 4-layer bandaging resulted in faster median healing times (20 vs. 43 weeks, p=0.03) than patients receiving usual treatments from their district nurse without 4-layer bandaging. During 12 month follow-up, clinic patients had a mean 5.9 extra ulcer-free weeks (95% CI: 1.2, 10.5). No difference in mean total NHS costs were found between the two groupsi.
(Health gain notation – 2 "likely to be beneficial")
Caveat: Study does not provide information on the relative impact of extra clinic nurse training, compression bandaging or protocols for referral and treatmentii. Validity of the magnitude of effect unknown due to observational bias resulting from non-blinded outcome assessment. 		i. Morrell CJ, Walters SJ, Dixon S, et al. Cost-effectiveness of community leg ulcer clinics: randomised controlled trial. British Medical Journal 1998;316:1487-91
(Type II evidence – randomised controlled trial of 233 ambulant patients randomised to clinic care or usual domiciliary district nurse care)
ii. Compression therapy for venous leg ulcers. Effective Health Care. Volume 3 Number 4. University of York: NHS Centre for Reviews and Dissemination 1997
http://www.york.ac.uk/inst/crd/ehc34.htm
(Type II evidence – summary review of randomised controlled trials)

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9.2h. There is no evidence that oral zinc sulphate is an effective treatment for promoting the healing of venous, arterial and sickle-cell leg ulcers. There is limited evidence of a beneficial effect in patients with low serum zinc and venous ulceri.
(Health gain notation – 4 "unknown")
Caveat: Included studies were of varying validity, settings and duration of follow-up. A well-designed large randomised controlled trial is required to determine the serum zinc concentration below which zinc therapy is beneficial.		 i. Wilkinson E, Hawke C. Does oral zinc aid the healing of chronic leg ulcers? Cochrane Review [Updated 14 August 1998]. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review of six randomised controlled trials, median size 33 patients)
9.2i. A Cochrane Review to determine the relative effectiveness of dressings used in the treatment of venous leg ulcers is due for publication in 1999i.
(Health gain notation – 4 "unknown")		 i. Palfreyman SJ, Michaels JA, Lochiel R, Nelson EA. Use of dressings in the treatment of venous leg ulcers. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)
9.2j. There is no evidence that ultrasound enhances cutaneous wound healingi. A Cochrane Review is due for publication in 1999ii.
(Health gain notation – 4 "unknown")
Caveat: Poor quality reviewi - methodology not stated, limited literature review, inclusion/exclusion criteria not stated, outcomes not pre-defined.		 i. Ernst E. Ultrasound for cutaneous wound healing. Phlebology 1995;10:2-4. In: Database of Reviews of Effectiveness. The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type II evidence – narrative review of five studies, including two randomised controlled trials)
ii. Flemming K, Cullum NA, Nelson EA. Therapeutic ultrasound for venous leg ulcers. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)

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9.2k. Cochrane Reviews on the effectiveness of laser therapyi and electrical stimulationii in the treatment of venous leg ulcers are due for publication in 1999.
(Health gain notation – 4 "unknown")		 i. Flemming K, Cullum NA. Laser therapy for the treatment of venous leg ulcers. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)
ii. Flemming K, Cullum NA. Electrical stimulation for venous leg ulcers. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)
9.2l. A Cochrane Review of reliable evaluations of topical analgesics, topical anaesthetics and dressings used to manage the pain of venous leg ulceration is due for publication in 1999i.
(Health gain notation – 4 "unknown")		 i. Briggs M, Nelson EA. Local interventions for chronic pain in venous leg ulcers. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)
9.3 Surgical management
9.3a. Surgical ligation of varicose veins has not been shown in randomised controlled trials to reduce recurrence rates of venous leg ulcersi. Saphenous ligationii and subfascial endoscopic ligationiii have been shown in small case series to heal ulcers and prevent recurrence. A Cochrane Review to determine the effectiveness of surgery in the treatment of deep venous incompetence is due for publication in 1999iv.
(Health gain notation – 4 "unknown")		 i. Compression therapy for venous leg ulcers. Effective Health Care. Volume 3 Number 4. University of York: NHS Centre for Reviews and Dissemination 1997
http://www.york.ac.uk/inst/crd/ehc34.htm
(Type II evidence – summary review of randomised controlled trials)
ii. Darke SG, Penfold C. Venous ulceration and saphenous ligation. European Journal of Vascular Surgery 1992;6(1):4-9
(Type IV evidence – case series of 213 patients)
iii. Pierik EG, Wittens CH, van Urk H. Subfascial endoscopic ligation in the treatment of incompetent perforating veins.
European Journal of Vascular & Endovascular Surgery 1995;9(1):38-41
(Type IV evidence – case series of 38 patients)
iv. Abidia A, Hardy SC. Surgical treatment of deep venous incompetence. Protocol for a Cochrane Review. In: The Cochrane Library, Issue 4. Oxford: Update Software, 1998
(Type I evidence – systematic review)
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Dr Alison Weightman, Protocol Enhancement Project, Duthie Library, UWCM, Cardiff CF4 4XN. e-mail: weightmanal@cardiff.ac.uk