Introduction
Chronic lower leg ulceration represents a serious medical and economic problem in Poland. In the years 2010-2011 expenditures dedicated to treatment of milder forms of chronic venous disease constituted 0.8% of the total healthcare budget, whereas expenses related to the treatment of ulcerations were at the level of 0.4%. The etiopathogenesis of leg ulcerations is immensely diverse [1]. Regarding the main pathogenic factors, the following types of ulcerations can be distinguished: venous, arterial, lymphatic, diabetic, immunological, mixed, and neoplastic. Ulcerations caused by venous incompetence account for 81% of all ulcers. Important elements in making a diagnosis of leg ulceration include medical history and physical examination. Physical examination is also important for studying such criteria as diameter of the ulcer, its colour, depth, and the presence of exudate and odour [2].
Appropriate management of venous ulcer should address the causal pathology, as well as additional abnormalities accompanying ulceration. Therapeutic measures should primarily decrease limb oedema, limit infection in the wound bed, provide an environment promoting wound healing, eliminate venous reflux, and improve blood flow in the case of venous obstruction. Such a causal treatment should correct haemodynamic disturbances leading to ulceration. This can be achieved either using surgical methods or sclerotherapy [3-6]. Topical treatment should be administered according to the TIME strategy, which involves tissue management, inflammation control, proper moisture maintenance, and stimulation of epithelialisation. Compression therapy is the main component of the treatment and was used even in antiquity, for example in ancient Egypt.
Venous ulceration poses a problem not only for the patient, but for the whole family and the community in which he or she lives. Pain in the wound area represents the most significant problem. Pain interferes with the patient’s daily activities and substantially lowers quality of life, leading to depression and refraining him/her from social activity [7-10].
Material and methods
The study was performed in a small town and reflects the real-life conditions and capabilities of the treatment far away from academic centres. The questionnaires assessing outcomes of the treatment of venous ulcerations were sent to 351 patients who were treated for leg ulcers in the specialised phlebological centre Duomed in Hajnówka in the years 2004-2011. We analysed the results of this treatment in 136 patients who answered this questionnaire. Patients were managed using short-stretch bandages, and topical Braunovidon dressings, which were recommended to be changed every 2-3 days. Pharmacological treatment comprised aescin taken orally. A flowchart of routine treatment is presented in Table 1. The study protocol was approved by the Local Bioethical Committee (approval No KB-256/2011).
Patients were aged 36-88 years, mean age 65.2 years. The majority of patients (60.5%) lived in rural areas, 26.1% of them lived in small towns – with less than 50,000 inhabitants, 8.2% came from bigger towns – with 50,000-200,000 inhabitants, and only 5.2% of patients lived in cities with more than 200,000 inhabitants. The majority of patients had only primary or vocational education (43.4% and 24.1% respectively), while the patients with at least secondary education were less numerous (secondary education – 25.7%, higher education – 5.2%, other – 3.9%). Most of the patients presented with co-morbidities, the most common comprised arterial hypertension (95.6%), ischaemic heart disease (86.0%), osteoarthrosis (38.2%), and diabetes mellitus (33.8%). The majority of our patients (85.7%) were overweight or obese.
All patients underwent venous ultrasound examination. Out of 136 patients with ulcerated legs, we found sonographic signs of superficial venous incompetence in 96 great saphenous veins (70.5%), 40 small saphenous veins (29.4%), 23 anterior accessory saphenous veins (16.9%), and 15 posterior accessory saphenous veins (11.0%). Regarding incompetent perforating veins, there were 36 legs (26.5%) with incompetent perforators in the medial aspect of the thigh, 78 (57.4%) with incompetent perforators in the anterior aspect of upper part of the lower leg, 66 (48.3%) with incompetent perforators in the medial aspect of upper part of the lower leg, 27 (19.9%) with incompetent perforators in the medial aspect of middle part of the lower leg, 85 (62.5%) with incompetent perforators in the posterior aspect of middle part of the lower leg, and 35 (25.7%) with incompetent perforators in the medial aspect of lower part of the lower leg. We also revealed incompetence of three femoral veins (2.2%), four popliteal veins (2.9%), and in one patient incompetence of the gastrocnemial veins (0.7%).
Statistical methods
Data were analysed using the PQStat 1.3.0 of the PQStat Software package and Microsoft Office Excel 2007. Basic descriptive statistics were calculated to obtain the arithmetical mean (M), standard deviation (SD), and minimum and maximum values. In all cases statistical significance was determined at the level of p < 0.05. The Lilliefors test was used to determine the normality of data, and parametric or nonparametric tests were carried out, accordingly. Regarding nonparametric data, the Wilcoxon signed-rank test with continuity correction was used for comparison of two dependent groups. To compare more than two independent groups, the nonparametric Kruskal-Wallis test was used. Regarding data that passed the normality test, the one-way ANOVA for independent groups was used. In addition, the Spearman’s rank-order correlation test and quantitative tests were carried out. Analysis of paired nominal variables was made using the McNemar test.
Results
After six months of the treatment at a specialised phlebological centre, in 70.59% of patients venous ulcers healed completely, they partially healed in 19.85% of patients, and did not heal in the remaining 9.56% (Fig. 1). Of note, while most of the ulcers associated with superficial venous incompetence healed within six months, ulcers that developed in the settings of deep venous incompetence or isolated incompetence of the perforators rarely healed during six months (Fig. 2). We also found that both pain and quality of life measured with the use of visual analogue scale significantly improved after the treatment (Figs. 3 and 4). The mean value of pain (a higher value means more pain) before the treatment was 6.7 and decreased after the treatment to 2.0. Quality of life (a higher value meant better quality of life) increased from 3.0 before the treatment to 6.0 after six months of therapy.
Discussion
Despite technological and medical advances in the treatment of chronic wounds, there still remain several unsolved problems. For example, there are a number of limitations and contraindications to the currently available treatments. Many venous ulcers occur in elderly patients (in our patients mean age was 65 years) presenting with co-morbidities, such as ischaemic heart disease, arterial hypertension, diabetes, arthritis, and obesity. This significantly limits the success of standard therapy. It has been demonstrated by many authors that venous ulceration is associated with decreased quality of life and high levels of pain [8, 11]. In the case of younger patients, an ulcer can represent an important cause of unemployment. Ulcers also have a negative effect on patients’ psychological state and restrict their mobility. High levels of pain reduce patients’ mobility, which in turn can result in abnormal function of the calf muscle pump.
Long-lasting venous hypertension is the direct cause of ulcer formation. Consequently, successful treatment of the ulcer is not possible without eliminating venous hypertension. Management of venous reflux has a positive influence on the healing of venous ulcers. Previous studies have demonstrated that classic stripping of incompetent saphenous veins significantly reduced venous pressure [12]. Thus, most likely, sclerotherapy of incompetent superficial veins in a similar manner eliminates venous hypertension. Sclerotherapy is a low-cost treatment modality and is accepted by most patients. Pathological refluxes can also be managed using other low-invasive endovascular methods, such as laser-, RF-, or steam ablation [13-17]. Van den Bos et al. demonstrated that endovenous thermal ablation and foam sclerotherapy are at least as effective as surgical treatment [12, 18]. The efficacy of sclerotherapy for the treatment of large diameter varicose veins is currently being debated. According to some reports, a properly prepared sclerosant, applied in the appropriate concentration, under ultrasound control, and following the guidelines of the Tegernsee consensus, is effective for the closure of large diameter venous trunks [10]. We found that sclerotherapy of incompetent veins can result in healing of recalcitrant venous ulcerations. Also, our treatment protocol improved patients’ quality of life and reduced the pain. In our patients who presented with venous ulcers, we found superficial venous incompetence in 66%, and incompetence of both superficial and deep veins in 25.7%, thus potentially a majority of ulcer patients could benefit from low-invasive treatments aimed at elimination of venous refluxes in the superficial veins.
The efficacy of the protocol for the treatment of venous leg ulcers depends on proper diagnosis and a tailored approach to each particular case. In contrast to monotherapy, a complex management of ulceration addresses different aspects of its pathophysiology. A number of studies have demonstrated that sclerotherapy effectively reduces reflux in the superficial veins, while compression treatment improves the function of muscle pump and decreases oedema. These measures should be accompanied by appropriate dressings. Such a combined treatment improves the haemodynamics of the venous system and promotes tissue regeneration, even in patients with long-lasting recalcitrant ulcers [7, 8, 12, 18, 19]. In addition, complex management of venous leg ulcers, accompanied by sclerotherapy of incompetent superficial veins, is safe, relatively inexpensive, and can be performed in an outpatient basis [20-25].
The authors declare no conflict of interest.
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