Guidelines for the management of chronic venous leg ulceration. Report of a multidisciplinary workshop

This document is the product of a multidisciplinary workshop held in November 1991 between the audit subcommittee of the British Association of Dermatologists and the Research Unit of the Royal College of Physicians. Partieipants included dermatologists, vascular surgeons, general practitioners, community nurses and physicians involved in care of the elderly. The text is based on papers submitted to, and presented and discussed at, the workshop, and on comments received in response to subsequent wide dissemination of the proceedings to speciality associations. Participants in the workshop, and contributors to the guidelines are: Dr B.R.Allen (Nottingham), Sister S.Bainsborough (Exeter), Professor K.Burnand (London), Professor D.Burrows (Belfast), Mr M.J.Caflam (Bedford), Dr G.W.Cherry (Oxford), Dr R.P.R.Dawber (Oxford). Dr W.S.Douglas (Airdrie), Dr A.Y.Finlay (Cardiff), Dr D.Gawkrodger (Sheffield), Dr D.J.Gould (Truro), Dr A.Hopkins (Royal College of Physicians, London), Dr D.McGibbon (London), Dr A.M.Middleton (London), Dr L.Millard (Nottingham), Dr L.Rhodes (Liverpool), Professor T.J.Ryan (Oxford), Dr N.B.Simpson (Newcastle), Dr F.D.Skerrett (Fowey). Dr J.M.Sowden (Nottingham), Miss L.A.Stone (London), Dr R.Williams (Rhyl). Papers presented to the workshop (copies available from the Royal College of Physicians of London):     

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Extensive calcification of the lower leg complicating venous ulceration

A case is presented of a severe variant of subcutaneous calcification complicating chronic venous ulceration of the lower leg.     

Diagnostic sensitivity of sonography in varicose and post-thrombotic venous insufficiency

We report on the application possibilities of sonography in phlebology. Sonographic examination of 131 lower legs showing various clinical forms of chronic venous insufficiency is discussed. Ultrasound offers a timesaving, non-invasive, and reproducible technique to detect insufficiencies concerning orifice or trunk of the great and lower saphenous veins as well as the perforating veins. The method allows varying diagnostic sensitivities. Thrombotic changes in the deep veins may be demonstrated with relative accurateness. As to insufficiencies concerning the epifascial and perforating venous system (in epifascial chronic venous insufficiency, stage I to IV), the question of surgical or sclerotherapeutic treatment can be settled in most cases according to the sonographical findings alone. Subfascial forms of chronic venous insufficiency require additional invasive diagnostic techniques, such as plethysmography, phlebography, and venous pressure measurements. In consideration of the high diagnostic importance of ultrasound, sonographic devices should be available and applied in a large number of phlebologic practices.     

Age-related rather than ulcer-related impairment of venous function tests in patients with venous ulceration

Various noninvasive tests of venous function and skin oxygenation were studied in 12 patients with unilateral venous ulcer and in 24 control subjects. In the ulcer patients, there was no difference between the leg with and the leg without ulcer regarding all the tests studied. Except for the maximal venous outflow, the patients and their age- and sex-matched controls did not differ with regard to all parameters studied. In contrast to these findings, ageing was associated with a reduction in maximum venous outflow, a shortening in venous filling time, an increase in venous pressure in the posterior tibial vein and a diminution of transcutaneous partial oxygen pressure.     

A new patient education approach in contact allergic dermatitis: the Contact Allergen Replacement Database (CARD)

BACKGROUND: When a patient is identified by patch testing as being sensitive to a specific contact allergen, he or she is generally advised to read the product labels and avoid products that contain the specific allergen. Patients are often confronted with difficult chemical names, synonyms, and cross-reactants for individual allergens. At the same time, dermatologists may spend a considerable amount of time trying to educate their patients about the avoidance of these allergens and explaining which products may contain them. METHODS: We applied a new educational approach to inform patients about products that are free of their allergens. RESULTS: We present a patient with multiple contact allergens in whom the Contact Allergen Replacement Database was used to educate about specific allergens. This approach has proved to be an invaluable tool for both physicians and their patients in contact allergy counseling.     

The effect of aspirin on haemostatic activity in the treatment of chronic venous leg ulceration

An increased rate of venous ulcer healing with the use of oral enteric-coated aspirin (300mg) daily has been reported.¹ Whether the effect of aspirin in this condition is related to its action on the haemostatic mechanism is unclear, and therefore this study aimed to assess the effect of aspirin on some haemostatic parameters in patients with chronic venous leg ulcers. A double-blind, randomized, placebo-controlled, parallel-group study of haemostatic activity and the effect of aspirin was implemented over a 4-month period. Twenty patients with venous leg ulcers, and 20 age- and sex-matched controls were studied. Patients received enteric-coated aspirin (300mg) or placebo (one tablet) daily for 4 months, in addition to standardized local compressive bandaging (Setopress®). Assessments made at recruitment, and at 2 and 4 months, included measurement of total ulcer surface area, haematological and biochemical screening, measurement of coagulation times, coagulation factor VIII:C (FVIII:C) and von Willebrand factor (vWF), and plasminogen activator inhibitor-1 (PAJ-1) levels. Procoagulant activity was assessed by a computer-assisted technique, to determine the rate of thrombin production in vitro. Patients with venous ulcers had increased levels of fibrinogen (P < 0.01), FVIII:C (P < 0.05), vWF (P < 0.05) and PAI-1 antigen (P < 0.01) compared with controls. Shortening of the coagulation rate, shown by a reduction of the time to generate 50% maxima! thrombin activity in seconds (T_5o), was seen in patients, in comparison with control subjects (P < 0.05). T₅₀ was longer in patients receiving aspirin than those receiving placebo, reflecting prolongation of coagulation rate in the aspirin-treated group. In addition, an increased rate of ulcer healing occurred in subjects receiving aspirin compared with the placebo-treated group (P < 0.01, P < 0.02 at 2 and 4 months, respectively). No significant change in fibrinogen, FVIII:C, vWF or PAI-1 levels occurred in either group during the 4-month period.