Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled Trial.

OBJECTIVE: The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking. METHODS: This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume. RESULTS: All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001). CONCLUSION: The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.

A Wearable Compression Device to Normalise Calf Muscle Pump Function in Chronic Venous Insufficiency for Each Postural Position.

BACKGROUND: For the currently used compression therapy, the applied compression pressure is usually inadequate to exert an effective impact on the veins in different body positions. The aim was to assess the venous ejection fraction achieved by a new compression device which automatically adjusts the interface pressure to body position in an acute experimental setting. METHODS: A new portable, battery driven compression device providing pressure adjusted to allow for body position, and connected to a less or very stiff calf cuff wrap was tested. In patients with superficial venous incompetence, the ejection fraction (EF) of the calf pump was measured by strain gauge plethysmography. Applied in a random sequence, values achieved without compression, with the two cuffs, and with compression stockings exerting 23-32 mmHg, were compared. The applied compression pressures were simultaneously recorded in the supine and standing positions, and during walking. Comfort was assessed by a visual analogue scale (VAS) with 0 corresponding to very low comfort and 10 to very comfortable. RESULTS: In 16 patients with CEAP clinical stage C3-C6, EF without compression was 37%, increasing to 46.9% with stockings, to 64.8% (p < .001) by less stiff and to 75.5% (p < .001) by stiffer wraps. The median interface pressure (supine/standing) was 31/56 mmHg for the less stiff device, 32/68 mmHg for the stiffer device, and 23/26 mmHg for the stockings. The static stiffness index and the walking pressure amplitudes were significantly higher than those generated by the stocking, and the highest values were found with the stiffer wrap material. The device comfort was high both in the supine and standing positions (VAS 8 ± 2). CONCLUSIONS: The tested devices were comfortable at rest and haemodynamically effective during walking by automatically adjusting compression pressures to body position. They are significantly more effective than elastic stockings in improving EF. The system is able to overcome the problems of fast pressure loss by continuously re-adjusting the compression pressure.

[Importance of adequate pressure in compression therapy : Basis for successful treatment]. / Bedeutung des adäquaten Drucks in der Kompressionstherapie : Basis der erfolgreichen Behandlung.

BACKGROUND: The pressure exerted by a compression device on a part of the body corresponds to the dosage of the compression therapy. Therefore, the pressure course under compression materials should be investigated in different clinical situations. MATERIAL AND METHODS: Pressure measurements were carried out under different compression materials in lying, standing and walking positions within the framework of training, self-experimentation and in patients with venous leg ulcers. RESULTS: The results showed that the pressure varied considerably depending on the material used, the firmness of application, the local configuration (body position) and the time interval between applications. A loss of pressure occurred under each compression therapy, especially under inelastic short-stretch material, mainly due to movement and edema reduction. This pressure loss is decisive for the timing of dressing changes and a reason for the good tolerance of high-pressure levels in mobile patients. CONCLUSION: Low pressures are particularly suitable for edema reduction. Hemodynamic effects require higher pressures (60-80 mmHg). For this purpose, inelastic materials are preferred which enable lower pressures when lying down (40-60 mmHg). As compression bandages are too loosely applied by many users, pressure indicators on bandages or adaptive bandages with templates are helpful to apply the material with the correct pressure. As a consequence of these findings it is postulated that, at least in studies comparing different compression media, pressure measurements should be carried out in the future, whereby the measuring point and body position should be documented.

A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness.

INTRODUCTION: Bandage application does not exert consistent compression pressure, leading to extremely variable compression when applied to patients. A new elastic bandage can exert a predefined pressure independently of healthcare providers and the size of the wrapped limb. The bandage system includes a series of non-stretchable patches that when applied to the bandage make it stiff. The aim of this work was to assess, in an experimental setting, the venous ejection fraction (EF) from the lower leg and the tolerability of this new bandage in a group of patients affected by superficial venous incompetence. METHODS: EF was measured using strain gauge plethysmography under baseline conditions and the bandage was applied with a supine pressure of 20 and 30 mmHg, with and without the stiff patches, in 25 patients with severe venous reflux in the great saphenous vein. The interface pressure of the bandages was measured simultaneously in the medial gaiter area. RESULTS: All patients showed EF values that were significantly reduced compared with normal individuals. Elastic bandages with an average pressure of 20 and 30 mmHg in the supine position achieved a slight improvement in EF, and, after applying non-stretchable patches on the same bandage with similar resting pressure, EF was restored to its normal range (p < .001). Improvement in EF correlates with the pressure differences between standing and lying pressure and between muscle systole and diastole during exercise. CONCLUSION: This study confirms that inelastic is much more effective than elastic compression for improving impaired venous haemodynamics. The test material can be applied with a predetermined pressure, which considerably enhances the consistency of application, and it is easily transformed into an inelastic system just by applying stiff patches without any stretch and without significantly increasing the comfortable supine pressure.

Compression therapy in patients with venous leg ulcers.

Wund-D.A.CH. is the umbrella organization of the various wound care societies in German-speaking countries. The present consensus paper on practical aspects pertinent to compression therapy in patients with venous leg ulcers was developed by experts from Germany, Austria, and Switzerland. In Europe, venous leg ulcers rank among the most common causes of chronic wounds. Apart from conservative and interventional wound and vein treatment, compression therapy represents the basis of all other therapeutic strategies. To that end, there are currently a wide variety of materials and systems available. While especially short-stretch bandages or multicomponent systems should be used in the initial decongestion phase, ulcer stocking systems are recommended for the subsequent maintenance phase. Another - to date, far less common - alternative are adaptive Velcro bandage systems. Medical compression stockings have proven particularly beneficial in the prevention of ulcer recurrence. The large number of treatment options currently available enables therapists to develop therapeutic concepts geared towards their patients' individual needs and abilities, thus resulting in good acceptance and adherence. Compression therapy plays a crucial role in the treatment of patients with venous leg ulcers. In recent years, a number of different treatment options have become available, their use and application differing among German-speaking countries. The present expert consensus is therefore meant to outline concrete recommendations for routine implementation of compression therapy in patients with venous leg ulcers.

Kompressionstherapie bei Patienten mit Ulcus cruris venosum.

Wund-D.A.CH. ist der Dachverband deutschsprachiger Fachgesellschaften, die sich mit den Thematiken der Wundbehandlung beschäftigen. Experten verschiedener Fachgesellschaften aus Deutschland, Österreich und der Schweiz haben nun einen aktuellen Konsens der Kompressionstherapie für Patienten mit Ulcus cruris venosum erstellt. In Europa ist das Ulcus cruris venosum eine der häufigsten Ursachen für chronische Wunden. Neben der konservativen und interventionellen Wund- und Venentherapie, ist die Kompressionstherapie die Basis der Behandlungsstrategien. Die Kompressionstherapie kann heute mit sehr unterschiedlichen Materialien und Systemen durchgeführt werden. Während in der Entstauungsphase insbesondere Verbände mit Kurzzugbinden oder Mehrkomponentensysteme zur Anwendung kommen, sind es anschließend überwiegend Ulkus-Strumpfsysteme. Eine weitere, bislang wenig verbreitete Alternative sind adaptive Kompressionsbandagen. Insbesondere für die Rezidivprophylaxe werden medizinische Kompressionsstrümpfe empfohlen. Durch die Vielzahl der heute zur Verfügung stehenden Behandlungsoptionen, kann für nahezu alle Patienten ein Konzept entwickelt werden, dass sich an den individuellen Bedürfnissen und Fähigkeiten orientiert und daher auch akzeptiert und durchgeführt wird. Die Kompressionstherapie ist für die Behandlung von Patienten mit Ulcus cruris venosum essentiell. In den letzten Jahren sind viele verschiedene Therapieoptionen verfügbar, die in den deutschsprachigen Ländern unterschiedlich angewendet oder durchgeführt werden. Daher soll dieser Expertenkonsens dazu beitragen, konkrete Empfehlungen für die praktische Durchführung der Kompressionstherapie von Patienten mit Ulcus cruris venosum darzustellen.

[New aspects of compression therapy]. / Neue Aspekte der Kompressionstherapie.

In this review article the mechanisms of action of compression therapy are summarized and a survey of materials is presented together with some practical advice how and when these different devices should be applied. Some new experimental findings regarding the optimal dosage (= compression pressure) concerning an improvement of venous hemodynamics and a reduction of oedema are discussed. It is shown, that stiff, non-yielding material applied with adequate pressure provides hemodynamically superior effects compared to elastic material and that relatively low pressures reduce oedema. Compression over the calf is more important to increase the calf pump function compared to graduated compression. In patients with mixed, arterial-venous ulcers and an ABPI over 0.6 inelastic bandages not exceeding a sub-bandage pressure of 40 mmHg may increase the arterial flow and improve venous pumping function.

Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centred approach.

A prospective, randomised, 12-week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four-layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient-perceived product performance and quality of life. Ulcer healing rate was similar (31·6% versus 42·3%, respectively, P = 0·30) between the treatments. Adverse events and patient-rated comfort were also similar. Average daily usage for the dual system was 10·5 and 1·8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0·68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0·04), skin protection (P < 0·001), removal ease (P = 0·0007), bathing (P < 0·0001) and sleep comfort (P = 0·0405). The adjusted final quality-of-life score was 0·1025 higher for adaptive compression (P = 0·0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0·0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four-layer bandage management but is better accepted and achieves higher patient-reported quality-of-life scores in these challenging patients.

Comparison of 4-Layer Bandages and an Adaptive Compression Therapy Device on Intended Pressure Delivery.

PURPOSE: To characterize and compare interface pressure profiles of an adaptive compression therapy (ACT) device and a traditional 4-layer bandage (4LB) system. DESIGN: A prospective, randomized, open-label, 1-arm, active controlled study. SUBJECTS: The sample comprised 12 healthy volunteers. METHODS: Subjects wore both devices for 8 hours on 3 consecutive days. Treatments were randomized to left and right legs. One clinician performed all applications and was experienced in the clinical use of both devices. Pressures were measured in seated and standing positions at the lower, mid, and upper calf immediately post application and after 1, 4, and 8 hours. RESULTS: Pressures achieved with the ACT were closer to targeted 40/30/20 mmHg graduated pressure values and were significantly less than the 4LB for corresponding sites/postures (P < .001). In the seated position, initial interface pressures (mean ± SD) for the ACT were 36.9 ± 4.9, 30.5 ± 4.5, and 21.0 ± 3.6 mmHg. Corresponding interface pressures for the 4LB were 52.5 ± 8.4, 57.5 ± 10.3, and 53.5 ± 12.9 mmHg. In the standing position, initial interface pressures for the ACT were 40.7 ± 4.8, 35.6 ± 4.5, and 21.1 ± 4.6 compared to 54.6 ± 12.5, 64.4 ± 10.9, and 53.7 ± 14.3 for the 4LB. At 1, 4, and 8 hours after application, the 4LB showed a significant progressive decline in interface pressure in both seated and standing positions (P < .001). Conversely, the ACT did not decrease over time and there was a slight but significant increase for lower and mid-calf sites in the seated position (P < .001). CONCLUSIONS: The ACT device provided more consistent interface pressures than the 4LB and the pressures achieved were consistent with contemporary venous ulcer therapy standards.

Dogmas and controversies in compression therapy: report of an International Compression Club (ICC) meeting, Brussels, May 2011.

The International Compression Club (ICC) is a partnership between academics, clinicians and industry focused upon understanding the role of compression in the management of different clinical conditions. The ICC meet regularly and from these meetings have produced a series of eight consensus publications upon topics ranging from evidence-based compression to compression trials for arm lymphoedema. All of the current consensus documents can be accessed on the ICC website (http://www.icc-compressionclub.com/index.php). In May 2011, the ICC met in Brussels during the European Wound Management Association (EWMA) annual conference. With almost 50 members in attendance, the day-long ICC meeting challenged a series of dogmas and myths that exist when considering compression therapies. In preparation for a discussion on beliefs surrounding compression, a forum was established on the ICC website where presenters were able to display a summary of their thoughts upon each dogma to be discussed during the meeting. Members of the ICC could then provide comments on each topic thereby widening the discussion to the entire membership of the ICC rather than simply those who were attending the EWMA conference. This article presents an extended report of the issues that were discussed, with each dogma covered in a separate section. The ICC discussed 12 'dogmas' with areas 1 through 7 dedicated to materials and application techniques used to apply compression with the remaining topics (8 through 12) related to the indications for using compression.

Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

Compression therapy in mixed ulcers increases venous output and arterial perfusion.

OBJECTIVES: This study was conducted to define bandage pressures that are safe and effective in treating leg ulcers of mixed arterial-venous etiology. METHODS: In 25 patients with mixed-etiology leg ulcers who received inelastic bandages applied with pressures from 20 to 30, 31 to 40, and 41 to 50 mm Hg, the following measurements were performed before and after bandage application to ensure patient safety throughout the investigation: laser Doppler fluxmetry (LDF) close to the ulcer under the bandage and at the great toe, transcutaneous oxygen pressure (TcPo(2)) on the dorsum of the foot, and toe pressure. Ejection fraction (EF) of the venous pump was performed to assess efficacy on venous hemodynamics. RESULTS: LDF values under the bandages increased by 33% (95% confidence interval [CI], 17-48; P < .01), 28% (95% CI, 12-45; P < .05), and 10% (95% CI, -7 to 28), respectively, under the three pressure ranges applied. At toe level, a significant decrease in flux of -20% (95% CI, -48 to 9; P < .05) was seen when bandage pressure >41 mm Hg. Toe pressure values and TcPo(2) showed a moderate increase, excluding a restriction to arterial perfusion induced by the bandages. Inelastic bandages were highly efficient in improving venous pumping function, increasing the reduced ejection fraction by 72% (95% CI, 50%-95%; P < .001) under pressure of 21 to 30 mm Hg and by 103% (95% CI, 70%-128%; P < .001) at 31 to 40 mm Hg. CONCLUSIONS: In patients with mixed ulceration, an ankle-brachial pressure index >0.5 and an absolute ankle pressure of >60 mm Hg, inelastic compression of up to 40 mm Hg does not impede arterial perfusion but may lead to a normalization of the highly reduced venous pumping function. Such bandages are therefore recommended in combination with walking exercises as the basic conservative management for patients with mixed leg ulcers.

The ICC Compression Questionnaire: A Comprehensive Tool to Evaluate Compression Materials or Devices Applied in Subjects with Lymphedema or Chronic Venous Disease.

Background: Compression therapy is an important part of the treatment of patients with lymphedema or chronic venous disease. However, there is no validated questionnaire evaluating the effect of compression and its acceptance by the patient. Therefore, the aims of this study were to construct a questionnaire evaluating the effect of compression and its acceptance by the patient, that is, the Dutch ICC Compression Questionnaire (ICC-CQ), to investigate its reliability and validity, and to translate it into English. Methods and Results: Eleven experts in applying compression and 51 Dutch patients with experience of using compression were involved in the construction process. One part of the ICC-CQ has to be completed by the patient and evaluates seven domains. The other part has to be completed by the health care provider and comprises three domains. Reliability and validity of the final version was investigated in a new group of 79 Dutch-speaking patients with lymphedema or chronic venous disease, wearing compression garments (N = 52) or bandages (N = 27). Except for one domain, the Intraclass Correlation Coefficients for test-rest/interrater reliability ranged from 0.55 to 0.93. Cronbach's alpha for internal consistency ranged from 0.71 to 0.97. Eighty-nine percent of the patients fully understood the questionnaire indicating good face validity, and 87% found it complete indicating good content validity. Construct validity was considered good since 10 out of 11 hypotheses were accepted. Conclusion: The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease.

Prospective, randomized, controlled trial comparing a new two-component compression system with inelastic multicomponent compression bandages in the treatment of leg lymphedema.

BACKGROUND: New, less-bulky, short-stretch compression bandages could be a valuable alternative in the management of lymphedema of the leg. OBJECTIVE: To compare the effectiveness of a two-component compression (2CC) system in the treatment of leg lymphedema with that of the traditional treatment with conventional inelastic multicomponent compression bandages (IMC). METHODS: Thirty hospitalized patients with moderate to severe unilateral lymphedema (stage II-III) of the leg were included. Patients were divided in two groups; one (n=15) received a 2CC, and the other (n=15) received IMC. Primary outcome was volume reduction of the affected leg; secondary outcome was loss of interface pressure. RESULTS: Median leg volumes before bandaging were 4,150 mL (2CC) and 4,360 mL (IMC). Median volume reduction after 2 hours was 120 mL (2.9%) with the 2CC system and 80 mL (1.8%) with IMC (p>.05). After 24 hours, volume reduction was 8.4% and 4.4% respectively (p>.05). Interface pressure dropped significantly within 2 hours of bandage application in both groups. CONCLUSION: Our results indicate that the 2CC system forms a suitable alternative to IMC in the conventional treatment of moderate to severe lymphedema.

Reticulate eruptions. Part 1: Vascular networks and physiology.

Reticulate pattern is one of the most important dermatological signs of a pathological process involving the superficial vascular networks. Vascular malformations, such as cutis marmorata congenita telangiectasia and benign forms of livedo reticularis, and sinister conditions, such as meningococcal meningitis or Sneddon's syndrome, can all present with a reticulate pattern. The clinical presentation and morphology is determined by the nature and extent of the underlying pathology and the involvement of a particular vascular network. This review has been divided into four instalments. In the present paper, we discuss the anatomy and physiology of the complex network of vascular structures that support the function of the skin and subcutis.

Reticulate eruptions: Part 2. Historical perspectives, morphology, terminology and classification.

Reticulate eruptions of vascular origin may represent an underlying arterial, venous, microvascular or combined pathology. In the presence of arterial pathology, individual rings are centred around ascending arterial vessels that supply the corresponding area of skin within an arterial hexagon that clinically presents with a blanched centre. Confluence of multiple arterial hexagons generates a stellate (star-like) pattern. In the presence of a primary venous pathology, individual rings correspond to the underlying reticular veins forming multiple venous rings. Focal involvement of a limited number of vessels presents with a branched (racemosa) configuration while a generalized involvement forms a reticulate (net-like) pattern. 'Livedo' refers to the colour and not the pattern of the eruption. Primary livedo reticularis (Syn. cutis marmorata) is a physiological response to cold and presents with a diffuse blanchable reticulate eruption due to vasospasm of the feeding arteries and sluggish flow and hyperviscosity in the draining veins. Livedo reticularis may be secondary to underlying conditions associated with hyperviscosity of blood. Livedo racemosa is an irregular, branched eruption that is only partially-blanchable or non-blanchable and always signifies a pathological process. Retiform purpura may be primarily inflammatory with secondary haemorrhage or thrombohaemorrhagic, as seen in disseminated intravascular coagulopathy.