The most commonly used scales for assessing patients with chronic venous disease and ulcers

Introduction

The term chronic venous insufficiency is reserved for an advanced form of chronic venous disorder (CVD), in which there are functional disorders of the venous system causing edema [1], skin lesions or venous ulcers of the lower limbs [2, 3]. The cause of abnormal venous outflow is the dysfunction of one or, more often, several mechanisms: valve efficiency, venous patency, vascular wall tension, muscle pump function [4]. These changes lead to the development of reflux and blood retention in one, two or three venous vessel systems. Disturbed blood outflow contributes to pathological increases in hydrostatic pressure above 90 mm Hg, i.e. so-called venous hypertension. This phenomenon is most clearly marked in the area of distal perforating veins; hence, the greatest intensity of skin lesions occurs in the area of the medial malleolus [5, 6]. Hemodynamic abnormalities in macrocirculation also cause microcirculation disorders [7]. The mechanisms lead to the development of trophic changes such as inflammation, thinning, and fibrosis of the skin and subcutaneous tissue, and as a result, create ideal conditions for the development of venous ulcers [8, 9].
Venous leg ulcers (VLUs) are considered to constitute 70% to 90% of ulcers located in the lower limbs [10] and manifest the most advanced stage of chronic venous insufficiency (CVI). The incidence of CVI and VLUs increases with age, and women are three times more likely to develop them than men [11]. Of great importance are the presence of hereditary and racial factors (predominant in Caucasians), as well as overweight (most patients are overweight), previous pregnancies (more often diagnosed in multiparous women), type of professional activity (work associated with long periods of standing or sitting), foot static disorders, excessive exposure to the sun, type of sports activity (strength sports), low-fiber diet, and constipation [12, 13]. Some of these factors can be minimized, for example, through lifestyle (increased physical activity, weight control, and avoiding smoking), but others are not modifiable, and many people will inevitably develop CVI over time [14]. The healing process of VLUs is complex and requires multifaceted interventions, both general and local. It has been reported that about 30% of wounds do not heal at an expected rate [15–18], and their median duration ranges from six to eight months [19] up to a year or even decades [20]. After healing, about one third of patients experience four or more relapses [21]. Many studies [22–24] have shown that VLUs cause disability in patients, negatively affecting their physical, mental, and social functioning, thus reducing their quality of life [25]. Therefore, in order to make a correct assessment and implement treatment, it is necessary to take into account many factors included in ready-made tools for classifying and assessing the severity of venous disorders.
The aim of the study was to describe the recommended tools for classification, diagnosis and assessment of the severity of CVI with VLUs and the quality of life of patients.

The importance of diagnostic testing in VLUs

Performing diagnostic tests is crucial when evaluating a patient with suspected venous ulcers. Diagnostic tests identify patients with venous hypertension who may benefit from noninvasive or invasive treatment of symptoms related to venous pathology, thereby reducing the incidence of ulcer recurrence. Of course, the gold standard in venous ulcer diagnostics is duplex ultrasound [26]. When evaluating a patient with venous disease, it is important to exclude concomitant peripheral artery disease, as it is estimated that mixed etiology affects up to 26% of patients with lower limb ulcers [27, 28].
For over 20 years, scales have been recommended to classify CVD severity and assess its severity and quality of life. These classifications have been improved over the years and are valuable instruments used in the care of patients with CVD, CVI, and VLUs. The scales most commonly used by clinicians appear to be the Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) Clinical Classification System, the Venous Clinical Severity Score (VCSS), the Villalta scale, and the CIVIQ-20 questionnaire.

CEAP classification

The development of a standardized clinical classification system for CVD is crucial for understanding the natural history of the disease, as well as for comparing methods of diagnosis and treatment. The clinical manifestations of CVD can vary greatly between patients with similar pathology, making it difficult to implement clinical scientific communication and practice guidelines without CVD reporting standards. For many years, the CEAP classification has been the primary tool for assessing the severity of CVD. The tool is used to precisely describe CVD and was developed from two parts: the CVD classification and the severity scoring system. The classification system describes the stages of chronic venous disease, using the acronym CEAP, which stands for clinical symptoms, etiology of venous disease (congenital or primary or secondarily acquired), anatomic distribution (superficial, perforating and/or deep veins) and pathological condition (obstruction and/or reflux). It is an internationally accepted standard for describing patients with chronic venous disorders based on clinical symptoms and the underlying venous pathology [29].
The CEAP classification was first published in 1995 [30] after a conference of international experts and endorsed by the joint Societies of Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery. The first update was in 2004 [31] and the most recent in 2020 [32]. The latest version of the CEAP classification added new categories for corona phlebectatica (C4c), recurrent varicose veins (C2r), and recurrent leg ulcers (C6r), a division of secondary etiology into venous (Esi) and nonvenous (Ese) causes, and new abbreviations for anatomical terms to replace the previously used numerical description [32]. Currently, most clinical publications on CVD and VLUs use the CEAP classification system or at least part of it. The CEAP system is an excellent descriptive tool for staging venous disease, but it cannot be used to assess the severity of venous disease because many of its components are relatively static. A disease severity scoring scheme must be measurable, with gradable components that may change in response to treatment. Some of the features, e.g. number of ulcers, duration of ulcers, ulcer recurrence, will not improve; the score may merely remain unchanged or increase [1]. Additionally, when assessing clinical symptoms, all patients with VLUs are classified as C6, and the tool does not provide much differentiation between patients from a clinical wound assessment perspective [33]. For this reason, the CEAP classification is not always used by VLU care providers. However, the tool is useful when patients have visible clinical symptoms, because higher classifications (C4 to C6) correlate with higher risk for ulcer development and recurrence [34]. In addition, the etiological, anatomical, and pathophysiological components of the CEAP classification include more detailed diagnostic workup that allows characterization of the venous disorder and possible treatment before ulceration develops. Duplex ultrasound can determine anatomical patterns of veins and venous flow abnormalities in the extremities. This information has a significant impact on the type of treatment considered most appropriate [35]. The CEAP classification system is presented in Table 1 (Figs. 1-9).

VCSS scale

In 2000, the American Venous Forum for Venous Outcomes developed the VCSS based on the best usable components of the CEAP classification. The goal was to improve the standardized assessment of venous disease outcomes based on gradable components that may change in response to therapy [1]. The VCSS consists of 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, ulcer size, and use of compression therapy), scored from 0 to 3 (total possible score, 30), that can be used to assess changes in response to therapy (Table 2). The VCSS was designed not to replace the CEAP classification but to complement it [1, 35] and to draw attention to the more severe manifestations of chronic venous disease (CEAP clinical class 4 and class 6). Linking VCSS to clinical CEAP provides a wealth of complementary information that improves communication [36].

Villalta scale

Post-thrombotic syndrome (PTS) is a common complication of deep venous thrombosis (DVT) that often leads to ulceration. It is estimated that about 25% of venous ulcers develop after DVT [37].
The incidence of primary venous insufficiency versus post-thrombotic damage as a cause of chronic venous insufficiency is not clearly defined, but is estimated to be about 80% post-thrombotic versus 20% primary valvular insufficiency. Although the vessel lumen is most often recanalized after an episode of deep vein thrombosis [38, 39], lysis is rarely complete. The residual clot is replaced by fibrous tissue, which may cause complete obstruction or adhesions formed by endothelial strands of residual clot. The valve leaflets may become damaged and collateral vessels develop, and the fibrotic process, which may extend to the outer part of the vein wall, may act as a functional obstruction. Perforating veins in the calf region may become important collateral vessels when the popliteal vein is occluded. The combination of popliteal vein obstruction and iliofemoral injury causes severe symptoms, often resulting in venous claudication and/or ulceration.
In clinical practice, PTS is diagnosed based on the presence of typical symptoms and clinical signs. In the 1990s, a clinical scale known as the Villalta scale was proposed as a measure that could be used to diagnose and classify the severity of PTS [40]. The Villalta scale was originally developed in a cross-sectional study of 100 consecutive patients who were assessed 6–36 months after deep vein thrombosis [41]. The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, itching) and six physician-rated physical symptoms (precalf edema, skin induration, hyperpigmentation, calf pain on pressure, venous ectasia, redness), which are rated on a four-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Points are awarded for each of these 11 descriptors according to severity (Table 1), from 0 for none to 3 for severe (Table 3). In addition, if venous ulceration was present, the severity of the condition was classified as severe, regardless of the presence or absence of other signs or symptoms. A score of 5–9 indicates mild disease, 10–14 moderate disease, and 15 severe disease. Points are summed to give a total score (range: 0–33). Individuals are classified as having PTS if the score is ≥ 5 or if there is a venous ulcer with previous DVT. In one cross-sectional study [42], the authors considered modernizing the scale with respect to, among other aspects, ulceration. Currently, only the presence or absence of ulceration is assessed. According to the authors of the cited paper, defining or assigning numerical scores for ulceration based on increasing ulcer severity (e.g., no ulceration, healed ulceration, one ulceration, > 1 ulceration) would improve the ability of the scale to distinguish between severe forms of PTS.

Diagnosis of venous leg ulcer

The diagnosis of venous ulcers depends on a thorough history and physical examination. During the history taking, it is necessary to assess risk factors such as a history of deep vein thrombosis, limb trauma (crush, fracture or surgery), congenital venous insufficiency, limited ankle mobility with impaired calf muscle pump (arthritis, paralysis, muscle disorders), pregnancy, congestive heart failure, family history of venous disease, obesity and advanced age. Women are three times more likely to develop venous ulcers than men [43]. Characteristic clinical features are presented in Tables 1 and 4 and include the presence of varicose veins, hyperpigmentation, lipodermatosclerosis and dermatitis. The shape of the lower limb may also be a clue, as an “inverted bottle” shape is a sign of lipodermatosclerosis. Venous ulcers tend to have flat edges, and long-standing ulcers may have ridged and undermined edges. Although most lower limb ulcers develop in the course of venous hypertension, sometimes the wound looks atypical (presence of necrotic tissue, exposed tendon, reticular cyanosis on the surrounding skin, or deep, “cut-out” ulceration), lasts for more than 6 months, or does not respond to standard treatment; in such a situation, other causes of its development should be suspected. Often, more detailed diagnostics are indicated, e.g. biopsy. Visual and palpation assessment alone may be insufficient. Objective examination is necessary to confirm the diagnosis, determine the etiology of the problem, and identify the anatomical site and severity of the disease [28, 44]. The characteristic symptoms of venous ulcers are presented in Table 4.

CIVIQ-20 questionnaire

The quality of life of patients with CVI and VLUs is an issue often discussed by many authors [45–48]. The impact of direct and indirect personal, financial, and social burdens is profound. For example, in the US health care system, the direct financial cost of treating VLUs resulting from wound infections, recurrences, and complication-related hospitalizations was $14.9 billion in 2012, and the concurrent psychological symptoms, such as depression, fatigue, anxiety, and sleep disturbance, associated with venous ulceration also involve high management costs [49]. However, such estimations of financial costs do not include patients’ costs and the indirect societal costs that result from absence from work [50]. Moreover, it is important to recognize that VLUs and their related burdens lower the patient’s quality of life. As a patient’s mental health may affect their ability to manage their overall health, following up on patients with VLUs, including inquiries into their psychological state, is of the utmost importance to ensure wound healing and good quality of life [48].
One of the most frequently used scales to assess the quality of life of patients with CVI and or VLUs is the CIVIQ-20 (Chronic Venous Insufficiency Questionnaire). It was developed in 1996 by Launois et al. [51] in France. The aim was to create a validated tool to assess the impact of CVI on the quality of life of patients with venous disorders. The CIVIQ is a valuable tool in clinical trials and practice, as it allows for the assessment of the subjective impact of venous disease on the patient’s life.
The 20 questions of the CIVIQ (Table 5) result in a global score and four separate domain scores: physical (items 5, 6, 7 and 9), psychological (items 12–20) and social impairment (items 8, 10 and 11), and level of pain (items 1–4). All questions have a 5-point response category, with higher scores reflecting more severe impairment. Three separate scores can be calculated: a score per item (1–5), a score of each of the four dimensions (0–100), and a global score (value 0–100). Higher scores represent lower health-related quality of life due to CVI or varicose veins [51].

Conclusions

Chronic venous disease and venous ulcers constitute a significant health, social, and economic problem. The presence of venous disease, in its advanced form, the development of venous ulcers, and long-term therapy significantly reduce the quality of life of patients. Early diagnosis and classification of the severity of venous disease using recommended tools can shorten the time of suffering and treatment of patients.

Disclosures

1. Institutional review board statement: Not applicable.
2. Assistance with the article: None.
3. Financial support and sponsorship: None.
4. Conflicts of interest: None.

References